Dalphene Index / Methodology
How every number in this index was produced
Every source, every query, every judgement call — published so it can be argued with.
Rules
| The four rules this index is built on |
|---|
| No value in any data file was invented. Every number, date and identifier came from a live API response captured during this run. |
| Anything that could not be resolved is null, and the reason is in the gaps list below. |
| No adverse-event data is fetched or stored. See sources_deliberately_excluded. |
| 510(k) = cleared. PMA / BLA / NDA = approved. Never the other way round. |
Every figure on the site is copied mechanically out of a public API response and linked back to the record it came from. Nothing is supplied by a manufacturer, nothing is estimated, nothing is filled in from memory.
An em-dash means the source record does not carry that value; hover it and it tells you why. It never means zero, it never means none, and it is never a rounded-down guess. 11 of the 136 products in the index carry em-dashes in their regulatory fields because no FDA record could be matched to the marketing name with confidence.
Cleared vs approved
| Pathway | Verb | Kind | In index | What it means |
|---|---|---|---|---|
| 510(k) | cleared | Device | 90 | The manufacturer showed FDA the device is substantially equivalent to a device already legally on the market. FDA did not review it for effectiveness against a placebo, did not endorse it, and did not approve it. Almost every aesthetic laser, RF and microneedling platform on this site. |
| PMA | approved | Device | 18 | Premarket approval: the strictest device pathway. Requires clinical evidence of safety and effectiveness for the stated indication. Dermal fillers on this site. |
| BLA | approved | Biologic | 7 | A biologics licence application. These products are biologics, not devices. The botulinum toxins on this site. |
| NDA | approved | Drug | 10 | A new drug application. The prescription topicals on this site. |
A clearance or an approval is a regulatory event. It is not evidence that a device will work on you, it says nothing about the operator holding it, and it is not a ranking. Where this site counts clearances, it is counting paperwork.
Glossary
Plain-English definitions of every abbreviation and piece of regulatory shorthand this site prints. The same sentences appear behind the question-mark icons on every page, because both come from one list.
How the FDA lets a product be sold
- 510(k)
- A submission in which a company shows the FDA that its device works much like a device already legally on sale, so the company does not have to prove the whole thing over from scratch.
- Substantial equivalence
- The finding at the heart of the 510(k) route: the FDA agrees the new device is as safe and as effective as one already on sale, and raises no new questions about either.
- Predicate device
- The device already on sale that a new submission compares itself against.
- No US authorization
- What this index says when it searched the FDA's clearance, approval and drug records for a product and none of them carried it, which is a different thing from not having looked, and a different thing again from the product being unsafe: several of these are sold normally in other countries.
- De Novo
- A route for a lower-risk device so new that nothing already on sale resembles it, which makes it the first of its kind and lets later devices compare themselves to it.
- PMA
- Premarket approval: the FDA's most demanding device review, in which the company has to hand over its own clinical evidence that the device is safe and does what it claims.
- BLA
- Biologics licence application: the route used for products grown or purified from living sources, such as botulinum toxins.
- NDA
- New drug application: the route used for a new drug, including injectable products regulated as drugs rather than as devices.
- HCT/P
- Human cells, tissues, and cellular and tissue-based products: the category for anything made from donated human tissue, such as skin, bone or fat, which the FDA handles under its own rulebook rather than as a device or a drug.
- Tissue establishment registration
- The listing a company files with the FDA saying it recovers, processes or distributes human tissue, which lets the FDA know the company exists and inspect it, and which is not a review of any product the company makes.
- FDA registered
- A phrase that means a company has told the FDA it exists and what it handles, which the FDA does not treat as approval, clearance or endorsement of anything that company sells.
- Minimal manipulation
- The test for whether donated tissue has been processed so lightly that it still does the same job it did in the donor's body, which is one of the conditions for staying on the lighter tissue rulebook instead of needing a full FDA review.
- Homologous use
- The test for whether donated tissue is being used for the same purpose it served in the donor's body, so donated skin used as skin passes and donated skin used for something else does not, which is the other condition for staying on the lighter tissue rulebook.
- Marketing authorization
- The general term for whatever permission a country requires before a product can be sold there, which is useful because the same product can need a different kind of permission in each country.
- Cleared
- The word for a product that came through the 510(k) route, where the FDA agreed it works much like something already on sale.
- Approved
- The word for a product whose maker submitted its own clinical evidence and had it accepted by the FDA, which is the premarket approval, biologics and new-drug routes.
- Cleared vs approved
- Cleared means the FDA agreed a device resembles one already on sale, while approved means the FDA read the maker's own clinical evidence and accepted it, so the two words describe different amounts of review and are not interchangeable.
- Class I
- The FDA's lowest-risk group of devices, such as simple hand tools, most of which need no submission before going on sale.
- Class II
- The FDA's middle-risk group, which is where most aesthetic lasers, energy devices and fillers sit, and which normally reaches the market through the 510(k) route.
- Class III
- The FDA's highest-risk group, which normally has to go through the full premarket approval review with the maker's own clinical evidence.
- K-number
- The reference the FDA stamps on a 510(k) submission, written like K123456, which is how you pull up the exact record for a device.
- Product code
- A three-letter FDA code naming a type of device rather than a brand, so every submission for that type of device carries the same code.
- Applicant
- The company named on an FDA submission, which can be the maker, its parent company or the distributor that sells the device.
- Decision date
- The date the FDA recorded its decision on a submission, which is the date this site counts a clearance under.
- Indication for use
- The specific job the FDA record says a product is meant to do, which can be narrower than the uses it is marketed for.
- 21 CFR
- The part of the United States rulebook that covers food and drugs, so a number like 21 CFR 878.4810 points at the specific rule governing one type of device.
- MAUDE
- The FDA's public file of problem reports sent in about devices; this site prints no counts from it, because anyone may file a report and nobody counts how many treatments were performed, so the numbers cannot be turned into a rate.
- openFDA
- The FDA's own public data service, which is where every clearance record on this site comes from.
How Europe records a device
- EUDAMED
- The European Union's public database where devices and their makers are listed, so an entry there records that a device exists in the European system and is not any kind of approval or clearance.
- Registered
- The word for a device that appears in the European database or in a study registry, meaning someone filed a record about it, not that any regulator judged it.
- Basic UDI-DI
- The European reference for a whole family of devices that share the same purpose and design, so several sizes or models sit under one of these.
- UDI-DI
- The European reference for one specific model, size or configuration of a device.
- CE mark
- The mark a manufacturer puts on a device to declare it meets the European Union's requirements, which is a separate system from anything the FDA does.
- Risk class
- Europe's own risk grouping for devices, which runs from I to III and does not line up one-to-one with the FDA's classes.
How studies are described
- ClinicalTrials.gov
- The United States public registry where the people running a study record it before or during the study, which is where this site's study counts come from.
- Registered study
- A study written into the public registry, which records that someone planned or ran it and says nothing about whether it finished or what it found.
- NCT number
- The reference the public study registry assigns to a study, written like NCT01234567.
- Pivotal trial
- The main study a company runs to show its product does what it claims, and usually the one a regulator leans on hardest.
- Enrolment
- How many people took part in a study.
- Actual enrolment
- The number of people a study finished with, recorded after it ran.
- Estimated enrolment
- The number of people the people running a study expected to recruit, recorded before the answer was known.
- Lead sponsor
- The organisation that takes responsibility for a study, which may be a manufacturer, a hospital, a university or a government body.
- Sponsor class
- The registry's grouping of who ran a study — a company, the national health agency, another government body, or the catch-all bucket that holds hospitals and universities.
- Industry sponsor
- A study whose responsible organisation is a company rather than a hospital, university or government body.
- Results posted
- Whether the people who ran a study later uploaded its actual outcome numbers to the public registry, which is a separate step from registering the study in the first place.
- Sponsor concentration
- How much of a group of studies sits with the single busiest organisation rather than being spread across many.
- Filing concentration
- How much of a group of FDA submissions sits with the single busiest company rather than being spread across many.
How published papers are labelled
- PubMed
- The United States National Library of Medicine's index of published medical literature, which is where this site's paper counts come from.
- Randomised controlled trial
- A study that decides by chance which participants get which treatment, so that the groups being compared start out alike and a difference at the end is easier to pin on the treatment.
- Systematic review
- A paper that hunts down every study on one question using a search method it states up front, then summarises what the whole set shows.
- Meta-analysis
- A paper that pools the numbers from several separate studies into a single combined figure.
- Clinical trial
- A broad label covering studies of many designs that test a treatment in people, which is why it always contains the randomised ones rather than sitting alongside them.
- Review
- A paper that surveys a topic in the author's own framing and contains no new patients of its own.
- Case report
- A write-up of one patient, or a small handful, described after the fact — useful as a sign that something can happen, and no guide at all to how often it does.
- Higher-tier evidence
- This site's shorthand for the pooled papers and the randomised trials counted together in one search, so a paper carrying both labels is only counted once.
- Publication type
- The label the literature index attaches to a paper to say what kind of work it is, which is assigned by the index rather than by this site.
Treatment vocabulary
- Modality
- A family of treatments that work the same way — such as radiofrequency microneedling, or lasers that leave the skin surface intact — rather than any one branded machine.
- Ablative
- A laser that removes the surface layer of skin so it heals back.
- Non-ablative
- A laser that heats tissue under the skin while leaving the surface layer intact.
- Ablative vs non-ablative
- An ablative laser removes the surface layer of skin, while a non-ablative one heats the tissue underneath and leaves the surface intact, which is a difference in how the energy is delivered rather than a ranking.
- Fractional laser
- A laser that treats the skin in a grid of tiny separate columns and leaves the skin between them untouched, instead of treating the whole surface at once.
- IPL
- Intense pulsed light: a device that fires a broad band of light wavelengths at once, unlike a laser, which fires a single one.
- BBL
- Broadband light: one manufacturer's name for its intense pulsed light platform.
- RF
- Radiofrequency: energy that heats tissue from the inside by passing an electrical current through it rather than by shining light on it.
- Nd:YAG
- A common laser crystal, named after the material it is made from, whose light reaches deeper into tissue than most other aesthetic lasers.
- LED
- Light-emitting diode: a low-power light source used in panels and masks, which produces far weaker light than a laser.
- HIFEM
- High-intensity focused electromagnetic energy: a body-contouring approach that makes muscle contract rather than heating or cooling fat.
- Microneedling
- A treatment that makes controlled micro-punctures in the skin to provoke a healing response; some machines also pass heat down the needles.
- Neuromodulator
- An injected product that temporarily relaxes a muscle, which is the category botulinum toxin products sit in.
- Dermal filler
- An injected gel that adds volume under the skin.
How this index counts
- Crosswalk
- The mapping this site keeps between records that no single source links up, such as tying a brand name to the FDA codes and the study searches that describe the same thing.
- Proxy ranking
- A ranking built from something that can actually be counted, such as published papers, standing in for something nobody can count directly, such as how well a treatment works.
- Clearance
- One 510(k) decision on the FDA's record, so a product line with several submissions behind it shows up as several of these.
- Narrow codes
- The FDA device codes on this site that describe unmistakably aesthetic equipment, so counts built from them leave out general-purpose surgical kit.
- Broad codes
- FDA device codes that cover mixed uses, where aesthetic equipment shares a code with general medical equipment.
- Trailing 365 days
- The most recent twelve months of records counted back from the last refresh, rather than a calendar year.
- Partial year
- A year that has not finished, so its count covers only the part of the year already on record.
- Median
- The middle value once everything is lined up in order, which a few unusually large or small entries cannot drag around.
- Q1
- The value a quarter of the way up the list, so a quarter of the entries sit below it.
- Q3
- The value three quarters of the way up the list, so a quarter of the entries sit above it.
- IQR
- Interquartile range: the stretch covering the middle half of the values, from a quarter of the way up the list to three quarters of the way up.
Sources
| Source | Used for | Endpoint | Licence |
|---|---|---|---|
| openFDA Device Classification | Authoritative product-code names, definitions, CFR regulation numbers and device classes. | https://api.fda.gov/device/classification.json | terms → |
| openFDA 510(k) Clearances | Recent clearance decisions by product code, and brand-to-K-number crosswalk. | https://api.fda.gov/device/510k.json | terms → |
| openFDA PMA (Premarket Approval) | Dermal filler approvals and supplements. | https://api.fda.gov/device/pma.json | terms → |
| openFDA Drugs@FDA | BLA/NDA applications for neuromodulators and topicals. | https://api.fda.gov/drug/drugsfda.json | terms → |
| NCBI E-utilities (PubMed esearch) | Publication counts per modality. | https://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi | terms → |
| ClinicalTrials.gov API v2 | Registered-study counts per modality, total and recruiting. | https://clinicaltrials.gov/api/v2/studies | terms → |
Exact URL templates for every call
| Template | URL |
|---|---|
| openfda_classification | https://api.fda.gov/device/classification.json?search=product_code:"{code}"&limit=1 |
| openfda_510k_by_code | https://api.fda.gov/device/510k.json?search=product_code:({codes})+AND+decision_date:[{start}+TO+{end}]&sort=decision_date:desc&limit={limit}&skip={skip} |
| openfda_510k_by_name | https://api.fda.gov/device/510k.json?search=device_name:"{name}"&sort=decision_date:desc&limit=100 |
| openfda_510k_by_applicant | https://api.fda.gov/device/510k.json?search=applicant:"{applicant}"&sort=decision_date:desc&limit=100 |
| openfda_pma_by_trade_name | https://api.fda.gov/device/pma.json?search=trade_name:"{name}"&sort=decision_date:asc&limit=100 |
| openfda_drugsfda_by_brand | https://api.fda.gov/drug/drugsfda.json?search=openfda.brand_name:"{name}"&limit=10 |
| pubmed_esearch | https://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term={term} |
| ctgov_studies | https://clinicaltrials.gov/api/v2/studies?query.intr={intr}&query.cond={cond}&countTotal=true&pageSize=1&fields=NCTId |
| ctgov_studies_recruiting | https://clinicaltrials.gov/api/v2/studies?query.intr={intr}&query.cond={cond}&filter.overallStatus=RECRUITING&countTotal=true&pageSize=1&fields=NCTId |
Attribution
FDA data retrieved through openFDA is US Government work in the public domain; openFDA does not endorse this site and FDA has not reviewed it. PubMed data is used courtesy of the National Library of Medicine. ClinicalTrials.gov data is provided by the National Library of Medicine under its terms of use. Neither NLM nor FDA is affiliated with, sponsors or endorses the Dalphene Index.
Two public endpoints are deliberately never called: MAUDE device adverse events, FAERS drug adverse events. The reasons are in “Not published” below.
Allowlist
The curated allowlist of FDA device product codes the Dalphene Index treats as medical-aesthetic.
It is NOT the FDA's own definition of 'aesthetic'. The FDA has no such category. This is an editorial curation, and every inclusion and exclusion is stated below so it can be argued with.
| Category | Codes | Narrow | Broad mixed | Product codes |
|---|---|---|---|---|
| Lasers & Light | 11 | 10 | 1 | GEX, NUV, OAP, OHS, OHT, OLP, ONE, ONF, ONG, PDZ, QHF |
| RF & Microneedling | 8 | 7 | 1 | GEI, MWY, ONQ, OUB, OUH, PAY, PBX, QAI |
| Injectables | 0 | 0 | 0 | |
| Body Contouring | 10 | 9 | 1 | NGX, OHV, OLI, OOK, ORK, OUP, OYW, PKT, QKL, SGT |
| Skin & Topicals | 2 | 2 | 0 | OZC, QPE |
| Breadth | What it means |
|---|---|
| narrow | The product code is defined for an aesthetic indication. Records under it belong in an aesthetics index. |
| broad mixed | The product code is genuinely shared with non-aesthetic medicine. Included because excluding it would delete most of the real aesthetic market. Every record sourced from a broad_mixed code is flagged. |
The allowlist decides what counts as an aesthetic device on this site. FDA has no aesthetic category, so this is an editorial judgement, published in full so it can be argued with. Being on the list says nothing about a device's quality; it says only that clearances filed under that code belong in an aesthetics index.
How the list was built
Walked the openFDA device classification endpoint: device_name searches for laser, radiofrequency, phototherapy, hair removal, wrinkle, acne, microneedling and body contouring, plus a full enumeration of every product code under 21 CFR 878.4810, 878.4400, 878.4430, 878.5400, 878.4340, 878.4590 and 890.5850. Each code was then included or rejected by hand.
NGXStimulator, Muscle, Powered, For Muscle Conditioning21 CFR 890.5850 · Class II · Physical Medicine · broad mixed
Why it is in. Stimulator, Muscle, Powered, For Muscle Conditioning (21 CFR 890.5850) - the code used by high-intensity electromagnetic and EMS body-contouring platforms. Also carries generic rehab/fitness muscle stimulators, so records are flagged broad_mixed.
FDA definition of this code. A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption21 CFR 878.4590 · Class II · General, Plastic Surgery · narrow
Why it is in. Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption (21 CFR 878.4590) - microfocused/intense ultrasound lifting and tightening platforms.
FDA definition of this code. A device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for non-invasive aesthetic use.
OLIFat Reducing Low Level Laser21 CFR 878.5400 · Class II · General, Plastic Surgery · narrow
Why it is in. Fat Reducing Low Level Laser (21 CFR 878.5400) - non-invasive fat-layer reduction for body contouring.
FDA definition of this code. Non-invasive reduction in fat layer for body contouring
OOKDermal Cooling Pack/Vacuum/Massager21 CFR 878.4340 · Class II · General, Plastic Surgery · narrow
Why it is in. Dermal Cooling Pack/Vacuum/Massager (21 CFR 878.4340) - this is the cryolipolysis code. Definition names adipocyte disruption for body contouring.
FDA definition of this code. The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
ORKLaser Assisted Lipolysis21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Laser Assisted Lipolysis - surgical laser lipolysis; included because it sits inside the aesthetic body-contouring decision set even though it is invasive.
FDA definition of this code. Intended to be used for laser assisted lipolysis
OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite21 CFR 878.4790 · Class II · General, Plastic Surgery · narrow
Why it is in. Powered Surgical Instrument For Improvement In The Appearance Of Cellulite - tissue-release cellulite devices.
FDA definition of this code. Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
OYWLaser, Cellulite Appearance21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Laser, Cellulite Appearance - cellulite laser treatment.
FDA definition of this code. For the removal of fat through laser lipolysis.
PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use21 CFR 878.5400 · Class II · General, Plastic Surgery · narrow
Why it is in. Laser For Disruption Of Adipocyte Cells For Aesthetic Use - the code name states the aesthetic intent.
FDA definition of this code. Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
QKLLipoaspirate Washing System For Aesthetic Body Contouring21 CFR 878.5040 · Class II · General, Plastic Surgery · narrow
Why it is in. Lipoaspirate Washing System For Aesthetic Body Contouring - the code name states the aesthetic intent.
FDA definition of this code. Wash, filter, concentrate, and or fragment autologous adipose tissue aspirated via liposuction for aesthetic body contouring without further manipulation
SGTElectromagnetic Stimulator For Healthy Muscle Stimulation21 CFR 890.5850 · Class II · Physical Medicine · narrow
Why it is in. Electromagnetic Stimulator For Healthy Muscle Stimulation - the newer electromagnetic muscle-stimulation code used by aesthetic body-contouring platforms.
FDA definition of this code. A device used for other than medical purposes to induce an electrical current to the body using a time-varying magnetic field to temporarily increase local blood flow and stimulate healthy muscles. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions.
GEXPowered Laser Surgical Instrument21 CFR 878.4810 · Class II · General, Plastic Surgery · broad mixed
Why it is in. Powered Laser Surgical Instrument (21 CFR 878.4810) - the primary code for aesthetic/dermatologic laser platforms (hair removal, vascular, pigment, resurfacing). Included despite breadth: it also carries non-aesthetic surgical lasers (urology, ENT), so records are flagged broad_mixed.
FDA definition of this code. A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
NUVMassager, Vacuum, Light Induced Heating21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Massager, Vacuum, Light Induced Heating - defined for temporarily altering the appearance of cellulite. Aesthetic by definition.
FDA definition of this code. The device is intended to temporarily alter the appearance of cellulite
OAPLaser, Comb, Hair21 CFR 890.5500 · Class II · Physical Medicine · narrow
Why it is in. Laser, Comb, Hair - low-level laser hair-growth devices; hair restoration is an aesthetic service line.
FDA definition of this code. Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v
OHSLight Based Over The Counter Wrinkle Reduction21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Light Based Over The Counter Wrinkle Reduction - the at-home end of the same modality; kept so the index can show the OTC/professional split.
FDA definition of this code. Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.
OHTLight Based Over-The-Counter Hair Removal21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Light Based Over-The-Counter Hair Removal - at-home hair removal devices.
FDA definition of this code. Over-the-counter device uses thermal energy to kill hair follicles for hair removal.
OLPOver-The-Counter Powered Light Based Laser For Acne21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Over-The-Counter Powered Light Based Laser For Acne - at-home acne phototherapy.
FDA definition of this code. The device is intended for over-the-counter (otc) use to treat patients with mild to moderate acne vulgaris. The device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to treat mild to moderate acne vulgaris.
ONEPowered Light Based Non-Laser Surgical Instrument21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Powered Light Based Non-Laser Surgical Instrument - non-laser light platforms whose definition names dermatology/aesthetic use.
FDA definition of this code. A light based Non-Laser device typically indicated to be used for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Powered Light Based Non-Laser Surgical Instrument With Thermal Effect - this is the intense pulsed light (IPL) code.
FDA definition of this code. A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.
ONGPowered Laser Surgical Instrument With MicrobeamFractional Output21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Powered Laser Surgical Instrument With Microbeam/Fractional Output - fractional resurfacing lasers specifically.
FDA definition of this code. A LASER (Light Amplification by Stimulated Emission of Radiation) based device having coherence, collimated and typically monochromatic radiation. The laser output is in form of tiny beams in micro range. Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic to destroy, remove or coagulate tissue, generally soft tissue. Indication for Use can be general and/or specific. The classification regulation 21 CFR 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis - laser toenail treatment is sold chairside in aesthetic practices.
FDA definition of this code. For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).
QHFEnergy Based Device For Treatment Of Tattoos21 CFR 878.4810 · Class II · General, Plastic Surgery · narrow
Why it is in. Energy Based Device For Treatment Of Tattoos - tattoo removal is a core aesthetic-practice service line.
FDA definition of this code. To reduce formation of bubbles during laser treatment of tattoos
GEIElectrosurgical, Cutting & Coagulation & Accessories21 CFR 878.4400 · Class II · General, Plastic Surgery · broad mixed
Why it is in. Electrosurgical, Cutting & Coagulation & Accessories (21 CFR 878.4400) - the code under which most RF skin-tightening and RF-microneedling platforms are actually cleared. Included despite breadth: it also carries general-surgery electrosurgical generators, so records are flagged broad_mixed.
FDA definition of this code. Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
MWYSystem, Microwave, Hair Removal21 CFR 878.4400 · Class II · General, Plastic Surgery · narrow
Why it is in. System, Microwave, Hair Removal - microwave energy for hair removal; same service line, different energy.
—
ONQElectrosurgical Coagulation For Aesthetic21 CFR 878.4400 · Class II · General, Plastic Surgery · narrow
Why it is in. Electrosurgical Coagulation For Aesthetic - the code name states the aesthetic intent.
FDA definition of this code. For the treatment of spider vein or telangiectasia by thermocoagulation.
OUBInstrument For Treatment Of Hyperhidrosis21 CFR 878.4400 · Class II · General, Plastic Surgery · narrow
Why it is in. Instrument For Treatment Of Hyperhidrosis - microwave/energy sweat-gland treatment, sold as an aesthetic-practice service.
FDA definition of this code. Soft-tissue coagulation
OUHSkin Resurfacing Rf Applicator21 CFR 878.4400 · Class II · General, Plastic Surgery · narrow
Why it is in. Skin Resurfacing RF Applicator - RF resurfacing applicators, unambiguously aesthetic.
FDA definition of this code. Skin resurfacing
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction21 CFR 878.4420 · Class II · General, Plastic Surgery · narrow
Why it is in. Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction - at-home RF wrinkle devices.
FDA definition of this code. An electrosurgical device for over-the-counter aesthetic use is a device using radiofrequency energy to produce localized heating within tissues for non-invasive aesthetic use.
PBXMassager, Vacuum, Radio Frequency Induced Heat21 CFR 878.4400 · Class II · General, Plastic Surgery · narrow
Why it is in. Massager, Vacuum, Radio Frequency Induced Heat - RF + vacuum cellulite/contouring handpieces.
FDA definition of this code. Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
QAIPowered Microneedle Device21 CFR 878.4430 · Class II · General, Plastic Surgery · narrow
Why it is in. Powered Microneedle Device (21 CFR 878.4430) - the post-De Novo code for microneedling pens.
FDA definition of this code. A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
OZCOver The Counter Thermal Treatment For Acne.21 CFR 890.5740 · Class II · Physical Medicine · narrow
Why it is in. Over The Counter Thermal Treatment For Acne - at-home acne devices; acne is a core aesthetic-practice condition.
FDA definition of this code. For the treatment of mild to moderate inflammatory acne.
QPEPhototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incisions21 CFR 878.4880 · Class II · General, Plastic Surgery · narrow
Why it is in. Phototherapy Device For Reducing The Appearance Of Acute Post-Surgical Incision Scars - scar-appearance phototherapy, an aesthetic-appearance claim.
FDA definition of this code. This device consists of a light emitting device and a photoconverter gel and is intended to employ light energy for reducing the appearance of acute post-surgical incisions. This classification does not include products which contain drugs or biologics.
Rejected codes
| Code | FDA device name | Why it is out |
|---|---|---|
| BWA | Unit, Electrosurgical And Coagulation, With Accessories | General-purpose electrosurgical units. Not aesthetic. |
| HAM | Apparatus, Electrosurgical | General-purpose electrosurgery under 878.4400. No aesthetic indication in the code definition. |
| ILY | Lamp, Infrared, Therapeutic Heating | Infrared heating lamps for temporary pain relief. Used by some aesthetic manufacturers but the code itself is a heating lamp, not an aesthetic indication. |
| IPF | Stimulator, Muscle, Powered | General powered muscle stimulators (rehab/TENS). Too broad; the aesthetic subset is captured by NGX and SGT. |
| JOS | Electrode, Electrosurgical | Electrosurgical accessory. Not a platform. |
| KGL | Cabinet, Phototherapy (PUVA) | PUVA cabinets treat psoriasis and vitiligo. Medical dermatology, not medical aesthetics. |
| LNK | Laser For Gastro-Urology Use | Gastro-urology. Shares 878.4810; not aesthetic. |
| MUK | Electrosurgical Radiofrequency System, Stress Urinary Incontinence | Urogynecology (SUI). Shares 878.4400 with RF skin devices; not aesthetic. |
| NEY | System, Ablation, Microwave And Accessories | Therapeutic tissue ablation (oncology/surgical). Not aesthetic. |
| NHN | Powered Light Based Laser Non-Thermal Instrument (pain therapy) | Low-level laser cleared for adjunctive PAIN therapy under 890.5500. Different indication from aesthetic LLLT; including it would inflate the light category with pain devices. |
| NVK | Laser, Dental, Soft Tissue | Dental soft-tissue lasers. Same regulation (878.4810) as aesthetic lasers, different specialty entirely. |
| NXF | Gas, Laser Generating | Consumable laser gas, not a treatment device. Accessory-only. |
| OEL | Laser, Benign Prostatic Hyperplasia | Urology (BPH). Shares 878.4810; not aesthetic. |
| ONO | Neurosurgical Laser With MR Thermography | Neurosurgery. Shares 878.4810 with aesthetic lasers; not an aesthetic device. |
| OSD | Massager, Therapeutic, Pelvic Floor | Pelvic-floor therapy. Sold in some aesthetic practices but not an appearance indication. |
| PKO | Transparent Patch For Use In Treatment Of Tattoos | Single-use patch accessory used during tattoo laser treatment. Accessory, not a platform. |
| QCY | Laser Absorbing Particles | Adjunct particle suspension applied before laser treatment. Aesthetic-adjacent but an accessory, not a device a clinic evaluates on its own. |
| QIU | Intense Pulsed Light Device For Managing Dry Eye | IPL cleared for dry-eye disease (ophthalmology). Same energy, different clinical claim. |
| QPZ | Contact Cooling For Skin Lesion Pain Relief | Cooling for procedural pain relief, not a treatment device. |
| QQF | Skin Microneedling Manual/Automated Device (Export Only) | Export-only, unclassified (class N). No US clearance record to index. |
Clearance feed
Count of FDA 510(k) clearance decisions whose product code is on the Dalphene aesthetic allowlist. A clearance means FDA agreed the device is substantially equivalent to a legally marketed predicate. It is NOT an approval, NOT a measure of efficacy, NOT a measure of safety, and NOT a measure of sales. Manufacturers file multiple 510(k)s for the same platform (new applicators, new indications, new software), so clearance counts track filing activity, not the number of distinct products.
The feed is a single window: every 510(k) decision whose product code is on the allowlist and whose decision date falls inside it. Every row carries its own decision date and an age in days, so the site can re-window to 30, 90 or 180 days without fetching anything again. The front page defaults to narrow codes — the data file itself sets recommended_default_view to narrow — because of the caveat below.
The broad-mixed caveat, in full
Rows with code_breadth = 'broad_mixed' come from product codes (GEX, GEI, NGX) that also carry non-aesthetic devices. They are included because most real aesthetic platforms are cleared under them -- but they also pull in things like general-surgery electrosurgical generators and lithotripsy lasers that no med spa would ever buy. These rows have NOT been individually vetted as aesthetic. The UI should default to the narrow-code counts and offer the broad view as an explicit, labelled opt-in. Any chart that mixes them must say so on the chart.
| Category | Decisions | From narrow codes |
|---|---|---|
| Lasers & Light | 146 | 73 |
| RF & Microneedling | 71 | 13 |
| Body Contouring | 14 | 7 |
Decisions per product code (16 codes)
| Product code | Decisions |
|---|---|
| GEX | 73 |
| GEI | 58 |
| OHS | 39 |
| OHT | 18 |
| OAP | 8 |
| NGX | 7 |
| PBX | 6 |
| QAI | 5 |
| OLI | 5 |
| ONF | 3 |
| OLP | 2 |
| PAY | 2 |
| ONG | 2 |
| OHV | 1 |
| PDZ | 1 |
| SGT | 1 |
The 4 feed queries, verbatim
| Product codes | Query URL |
|---|---|
| GEX, ONG, ONF, ONE, QHF, OHS, OHT, OLP | https://api.fda.gov/device/510k.json?search=product_code:(%22GEX%22+%22ONG%22+%22ONF%22+%22ONE%22+%22QHF%22+%22OHS%22+%22OHT%22+%22OLP%22)+AND+decision_date:%5B2025-07-25+TO+2026-07-25%5D&sort=decision_date:desc&limit=100&skip=0 |
| PDZ, OAP, NUV, GEI, OUH, ONQ, QAI, PAY | https://api.fda.gov/device/510k.json?search=product_code:(%22PDZ%22+%22OAP%22+%22NUV%22+%22GEI%22+%22OUH%22+%22ONQ%22+%22QAI%22+%22PAY%22)+AND+decision_date:%5B2025-07-25+TO+2026-07-25%5D&sort=decision_date:desc&limit=100&skip=0 |
| PBX, MWY, OUB, OOK, OLI, PKT, ORK, OYW | https://api.fda.gov/device/510k.json?search=product_code:(%22PBX%22+%22MWY%22+%22OUB%22+%22OOK%22+%22OLI%22+%22PKT%22+%22ORK%22+%22OYW%22)+AND+decision_date:%5B2025-07-25+TO+2026-07-25%5D&sort=decision_date:desc&limit=100&skip=0 |
| OUP, OHV, NGX, SGT, QKL, QPE, OZC | https://api.fda.gov/device/510k.json?search=product_code:(%22OUP%22+%22OHV%22+%22NGX%22+%22SGT%22+%22QKL%22+%22QPE%22+%22OZC%22)+AND+decision_date:%5B2025-07-25+TO+2026-07-25%5D&sort=decision_date:desc&limit=100&skip=0 |
Why K-numbers link where they do
K-numbers link to the FDA 510(k) release-database record at accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm, keyed on the K-number itself. Where an identifier does not match the exact K-number shape, no link is built rather than a path being guessed at.
They deliberately do not link the clearance-letter PDF under accessdata.fda.gov/cdrh_docs. That path has to be assembled from the two-digit year inside the K-number, which is an assumption about FDA's file layout rather than a value any API returned, and FDA does not post a letter for every clearance, so some of those links 404 while the database record for the same clearance resolves fine. A source link that does not resolve is worse than no link.
Evidence queries
| Technique | Category | PubMed, all time | PubMed, 10y | Registered studies | Recruiting |
|---|---|---|---|---|---|
| Topical retinoid | Skin & Topicals | 4,253 | 1,332 | 343 | 14 |
| Exosome / extracellular-vesicle preparation | Injectables | 2,396 | 2,353 | 79 | 18 |
| Botulinum toxin (cosmetic) | Injectables | 2,201 | 1,362 | 186 | 4 |
| Pulsed dye laser | Lasers & Light | 1,530 | 613 | 72 | 3 |
| Ablative / hybrid fractional laser | Lasers & Light | 1,485 | 940 | 229 | 13 |
| Hyaluronic acid filler | Injectables | 1,298 | 1,033 | 46 | 3 |
| Non-ablative fractional laser | Lasers & Light | 1,157 | 742 | 128 | 10 |
| Topical hydroquinone / triple combination | Skin & Topicals | 1,116 | 509 | 51 | 4 |
| IPL / broadband light | Lasers & Light | 1,028 | 488 | 43 | 5 |
| Laser hair removal | Lasers & Light | 744 | 359 | 30 | 1 |
| Mechanical microneedling | RF & Microneedling | 619 | 564 | 135 | 13 |
| Poly-L-lactic acid collagen stimulator | Injectables | 586 | 371 | 17 | 0 |
| Calcium hydroxylapatite filler | Injectables | 582 | 408 | 7 | 0 |
| PDLLA / PLLA collagen biostimulator | Injectables | 450 | 336 | 49 | 6 |
| Monopolar RF skin tightening | RF & Microneedling | 432 | 293 | 9 | 1 |
| Radiofrequency microneedling | RF & Microneedling | 354 | 304 | 37 | 1 |
| Picosecond laser (pigment & tattoo) | Lasers & Light | 323 | 306 | 27 | 0 |
| Ultrasound lifting & tightening | Body Contouring | 317 | 261 | 16 | 1 |
| RF body contouring | Body Contouring | 255 | 174 | 0 | 0 |
| Cryolipolysis | Body Contouring | 245 | 199 | 20 | 0 |
| Hydradermabrasion | Skin & Topicals | 166 | 73 | 9 | 0 |
| Human acellular dermal matrix (ECM) booster | Injectables | 158 | 112 | 106 | 12 |
| Polynucleotide (PDRN) skin booster | Injectables | 155 | 121 | 16 | 2 |
| Bimatoprost for eyelash growth | Skin & Topicals | 128 | 52 | 28 | 0 |
| Non-invasive laser lipolysis | Body Contouring | 112 | 49 | 0 | 0 |
| Topical clascoterone | Skin & Topicals | 90 | 88 | 21 | 2 |
| Sebaceous-gland laser for acne | Lasers & Light | 66 | 40 | 5 | 1 |
| High-intensity electromagnetic muscle stimulation | Body Contouring | 61 | 61 | 4 | 0 |
| Cellulite septa release | Body Contouring | 50 | 45 | 4 | 0 |
Number of PubMed records matching a fixed, hand-written title/abstract query for the MODALITY, not the brand. It measures how much has been PUBLISHED about a technique. It is NOT a quality score, NOT an efficacy measure, NOT a count of randomised trials, and NOT comparable across modalities of different ages -- an older technique has had more years to accumulate papers. Query text is stored next to every count so you can run it yourself.
Number of studies registered on ClinicalTrials.gov matching a fixed intervention query ANDed with a cosmetic/dermatologic condition query. Registration is not completion, not publication, and not a result. Counts include studies of any status, size or sponsor. The recruiting count is a snapshot on the run date and will change.
Counts are computed per MODALITY, never per brand. Brand-name literature searches reward manufacturers with big marketing departments and punish equally good devices with quieter names. Ranking brands by their own name-hits would be a popularity contest dressed as evidence.
Each query was written by hand, versioned as v1-2026-07-25, and frozen. If a query changes, the version string changes with it and the old string stays on this page, because a count you cannot reproduce is not a count.
| Limitations that apply to every query on this list |
|---|
| Free-text [tiab] queries miss papers that describe a technique without using the query's vocabulary, and catch papers that mention it in passing. |
| Modalities with generic vocabulary (ultrasound, radiofrequency, microneedling) need broader constraint clauses, so their counts carry more noise than narrow terms like cryolipolysis. |
| The all-time PubMed count has no lower date bound, so indexing-era differences between fields are baked in. That is why the 10-year count is shown alongside it. |
| ClinicalTrials.gov registration practice varies by country and sponsor type; device studies are under-registered relative to drug studies. |
Cellulite septa releaseBody Contouring · 50 PubMed (45 in 10 years) · 4 registered, 0 recruiting
Products in the index using this technique: Aveli, Cellfina, Cellulaze. Query set v1-2026-07-25.
- PubMed, all time — 50 records
(("cellulite"[tiab]) AND (subcision[tiab] OR "septa release"[tiab] OR "tissue stabilized"[tiab] OR "manual subcision"[tiab] OR "targeted verifiable subcision"[tiab])) OR ("cellulite subcision"[tiab])run this query on PubMed →- PubMed, 10-year window — 45 records
(("cellulite"[tiab]) AND (subcision[tiab] OR "septa release"[tiab] OR "tissue stabilized"[tiab] OR "manual subcision"[tiab] OR "targeted verifiable subcision"[tiab])) OR ("cellulite subcision"[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 4 registered, 0 recruiting on the fetch date
- Intervention:
(subcision OR "tissue stabilized subcision" OR "cellulite release")Condition:(cellulite OR "edematous fibrosclerotic panniculopathy" OR cosmetic)run it → · recruiting only →
CryolipolysisBody Contouring · 245 PubMed (199 in 10 years) · 20 registered, 0 recruiting
Products in the index using this technique: CoolSculpting, CoolSculpting Elite. Query set v1-2026-07-25.
- PubMed, all time — 245 records
("cryolipolysis"[tiab] OR "cryolipolisis"[tiab] OR "cold-induced lipolysis"[tiab]) AND (fat[tiab] OR adipos*[tiab] OR "body contouring"[tiab] OR subcutaneous[tiab] OR abdomen[tiab] OR flank*[tiab])run this query on PubMed →- PubMed, 10-year window — 199 records
("cryolipolysis"[tiab] OR "cryolipolisis"[tiab] OR "cold-induced lipolysis"[tiab]) AND (fat[tiab] OR adipos*[tiab] OR "body contouring"[tiab] OR subcutaneous[tiab] OR abdomen[tiab] OR flank*[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 20 registered, 0 recruiting on the fetch date
- Intervention:
(cryolipolysis OR "cold-induced lipolysis")Condition:("body contouring" OR "subcutaneous fat" OR "abdominal fat" OR obesity OR cosmetic)run it → · recruiting only →
High-intensity electromagnetic muscle stimulationBody Contouring · 61 PubMed (61 in 10 years) · 4 registered, 0 recruiting
Products in the index using this technique: CoolTone, Emsculpt NEO. Query set v1-2026-07-25.
- PubMed, all time — 61 records
("high-intensity focused electromagnetic"[tiab] OR "HIFEM"[tiab] OR "high intensity focused electromagnetic"[tiab] OR ("electromagnetic"[tiab] AND "muscle stimulation"[tiab] AND "body contouring"[tiab])) AND (muscle*[tiab] OR abdomen[tiab] OR buttock*[tiab] OR "body contouring"[tiab] OR fat[tiab])run this query on PubMed →- PubMed, 10-year window — 61 records
("high-intensity focused electromagnetic"[tiab] OR "HIFEM"[tiab] OR "high intensity focused electromagnetic"[tiab] OR ("electromagnetic"[tiab] AND "muscle stimulation"[tiab] AND "body contouring"[tiab])) AND (muscle*[tiab] OR abdomen[tiab] OR buttock*[tiab] OR "body contouring"[tiab] OR fat[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 4 registered, 0 recruiting on the fetch date
- Intervention:
("HIFEM" OR "high intensity focused electromagnetic" OR "electromagnetic muscle stimulation")Condition:("body contouring" OR "muscle strengthening" OR "abdominal fat" OR cosmetic OR "body composition")run it → · recruiting only →
Non-invasive laser lipolysisBody Contouring · 112 PubMed (49 in 10 years) · 0 registered, 0 recruiting
Products in the index using this technique: Emerald Laser, SculpSure, Venus Bliss, Zerona. Query set v1-2026-07-25.
- PubMed, all time — 112 records
(("1060 nm"[tiab] OR "1,060 nm"[tiab] OR "hyperthermic laser"[tiab] OR "laser lipolysis"[tiab] OR "low-level laser"[tiab]) AND (lipolysis[tiab] OR "fat reduction"[tiab] OR "body contouring"[tiab] OR adipocyte*[tiab])) AND (noninvasive[tiab] OR non-invasive[tiab] OR subcutaneous[tiab] OR abdomen[tiab] OR flank*[tiab] OR skin[tiab])run this query on PubMed →- PubMed, 10-year window — 49 records
(("1060 nm"[tiab] OR "1,060 nm"[tiab] OR "hyperthermic laser"[tiab] OR "laser lipolysis"[tiab] OR "low-level laser"[tiab]) AND (lipolysis[tiab] OR "fat reduction"[tiab] OR "body contouring"[tiab] OR adipocyte*[tiab])) AND (noninvasive[tiab] OR non-invasive[tiab] OR subcutaneous[tiab] OR abdomen[tiab] OR flank*[tiab] OR skin[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 0 registered, 0 recruiting on the fetch date
- Intervention:
("laser lipolysis" OR "1060 nm laser" OR "low level laser fat reduction")Condition:("body contouring" OR "subcutaneous fat" OR "fat reduction" OR cosmetic)run it → · recruiting only →
RF body contouringBody Contouring · 255 PubMed (174 in 10 years) · 0 registered, 0 recruiting
Products in the index using this technique: Accent, Exilis, NuEra Tight, VelaShape, Venus Legacy, truSculpt, truSculpt iD. Query set v1-2026-07-25.
- PubMed, all time — 255 records
(("radiofrequency"[tiab] OR "radio-frequency"[tiab]) AND ("body contouring"[tiab] OR "fat reduction"[tiab] OR "circumference reduction"[tiab] OR cellulite[tiab] OR adipos*[tiab])) AND (noninvasive[tiab] OR non-invasive[tiab] OR abdomen[tiab] OR flank*[tiab] OR thigh*[tiab] OR skin[tiab])run this query on PubMed →- PubMed, 10-year window — 174 records
(("radiofrequency"[tiab] OR "radio-frequency"[tiab]) AND ("body contouring"[tiab] OR "fat reduction"[tiab] OR "circumference reduction"[tiab] OR cellulite[tiab] OR adipos*[tiab])) AND (noninvasive[tiab] OR non-invasive[tiab] OR abdomen[tiab] OR flank*[tiab] OR thigh*[tiab] OR skin[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 0 registered, 0 recruiting on the fetch date
- Intervention:
("radiofrequency body contouring" OR "radiofrequency fat reduction" OR "radiofrequency lipolysis")Condition:("body contouring" OR "subcutaneous fat" OR cellulite OR cosmetic)run it → · recruiting only →
Ultrasound lifting & tighteningBody Contouring · 317 PubMed (261 in 10 years) · 16 registered, 1 recruiting
Products in the index using this technique: Sofwave, Ultherapy. Query set v1-2026-07-25.
- PubMed, all time — 317 records
("microfocused ultrasound"[tiab] OR "micro-focused ultrasound"[tiab] OR "intense focused ultrasound"[tiab] OR ("ultrasound"[tiab] AND "skin tightening"[tiab]) OR ("ultrasound"[tiab] AND "skin laxity"[tiab])) AND (skin[tiab] OR face[tiab] OR facial[tiab] OR neck[tiab] OR cutaneous[tiab])run this query on PubMed →- PubMed, 10-year window — 261 records
("microfocused ultrasound"[tiab] OR "micro-focused ultrasound"[tiab] OR "intense focused ultrasound"[tiab] OR ("ultrasound"[tiab] AND "skin tightening"[tiab]) OR ("ultrasound"[tiab] AND "skin laxity"[tiab])) AND (skin[tiab] OR face[tiab] OR facial[tiab] OR neck[tiab] OR cutaneous[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 16 registered, 1 recruiting on the fetch date
- Intervention:
("microfocused ultrasound" OR "micro-focused ultrasound" OR "intense focused ultrasound")Condition:("skin laxity" OR wrinkles OR "facial rejuvenation" OR skin OR cosmetic)run it → · recruiting only →
Botulinum toxin (cosmetic)Injectables · 2,201 PubMed (1,362 in 10 years) · 186 registered, 4 recruiting
Products in the index using this technique: Botox Cosmetic, Daxxify, Dysport, Jeuveau, Letybo, Xeomin. Query set v1-2026-07-25.
- PubMed, all time — 2,201 records
("botulinum toxin"[tiab] OR onabotulinumtoxinA[tiab] OR abobotulinumtoxinA[tiab] OR incobotulinumtoxinA[tiab] OR prabotulinumtoxinA[tiab] OR daxibotulinumtoxinA[tiab]) AND ("glabellar"[tiab] OR "crow's feet"[tiab] OR "lateral canthal"[tiab] OR "forehead lines"[tiab] OR rhytid*[tiab] OR wrinkle*[tiab] OR cosmetic[tiab] OR aesthetic[tiab])run this query on PubMed →- PubMed, 10-year window — 1,362 records
("botulinum toxin"[tiab] OR onabotulinumtoxinA[tiab] OR abobotulinumtoxinA[tiab] OR incobotulinumtoxinA[tiab] OR prabotulinumtoxinA[tiab] OR daxibotulinumtoxinA[tiab]) AND ("glabellar"[tiab] OR "crow's feet"[tiab] OR "lateral canthal"[tiab] OR "forehead lines"[tiab] OR rhytid*[tiab] OR wrinkle*[tiab] OR cosmetic[tiab] OR aesthetic[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 186 registered, 4 recruiting on the fetch date
- Intervention:
("botulinum toxin" OR onabotulinumtoxinA OR abobotulinumtoxinA OR incobotulinumtoxinA OR daxibotulinumtoxinA)Condition:("glabellar lines" OR "facial wrinkles" OR rhytides OR "crow's feet" OR cosmetic)run it → · recruiting only →
Calcium hydroxylapatite fillerInjectables · 582 PubMed (408 in 10 years) · 7 registered, 0 recruiting
Products in the index using this technique: Radiesse. Query set v1-2026-07-25.
- PubMed, all time — 582 records
("calcium hydroxylapatite"[tiab] OR "calcium hydroxyapatite"[tiab]) AND ("dermal filler"[tiab] OR "soft tissue"[tiab] OR facial[tiab] OR aesthetic[tiab] OR cosmetic[tiab] OR skin[tiab] OR nasolabial[tiab])run this query on PubMed →- PubMed, 10-year window — 408 records
("calcium hydroxylapatite"[tiab] OR "calcium hydroxyapatite"[tiab]) AND ("dermal filler"[tiab] OR "soft tissue"[tiab] OR facial[tiab] OR aesthetic[tiab] OR cosmetic[tiab] OR skin[tiab] OR nasolabial[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 7 registered, 0 recruiting on the fetch date
- Intervention:
("calcium hydroxylapatite" OR "calcium hydroxyapatite filler")Condition:("nasolabial folds" OR "facial wrinkles" OR "skin laxity" OR "hand augmentation" OR cosmetic)run it → · recruiting only →
Exosome / extracellular-vesicle preparationInjectables · 2,396 PubMed (2,353 in 10 years) · 79 registered, 18 recruiting
Products in the index using this technique: ASCE+. Query set v2-2026-08-02.
- PubMed, all time — 2,396 records
(exosome*[tiab] OR "extracellular vesicle*"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR dermatolog*[tiab] OR rejuvenation[tiab] OR aesthetic*[tiab])run this query on PubMed →- PubMed, 10-year window — 2,353 records
(exosome*[tiab] OR "extracellular vesicle*"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR dermatolog*[tiab] OR rejuvenation[tiab] OR aesthetic*[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 79 registered, 18 recruiting on the fetch date
- Intervention:
(exosome OR "extracellular vesicles")Condition:(skin OR rejuvenation OR wrinkles OR alopecia OR photoaging)run it → · recruiting only →
Human acellular dermal matrix (ECM) boosterInjectables · 158 PubMed (112 in 10 years) · 106 registered, 12 recruiting
Products in the index using this technique: CellREDM, Elravie Re2O, Juveacell. Query set v2-2026-08-02.
- PubMed, all time — 158 records
("acellular dermal matrix"[tiab] OR "acellular dermis"[tiab] OR "dermal matrix"[tiab]) AND (injectable[tiab] OR inject*[tiab] OR micronized[tiab] OR particulate*[tiab] OR powder*[tiab]) AND (skin[tiab] OR dermal[tiab] OR rejuvenation[tiab] OR aesthetic*[tiab])run this query on PubMed →- PubMed, 10-year window — 112 records
("acellular dermal matrix"[tiab] OR "acellular dermis"[tiab] OR "dermal matrix"[tiab]) AND (injectable[tiab] OR inject*[tiab] OR micronized[tiab] OR particulate*[tiab] OR powder*[tiab]) AND (skin[tiab] OR dermal[tiab] OR rejuvenation[tiab] OR aesthetic*[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 106 registered, 12 recruiting on the fetch date
- Intervention:
("acellular dermal matrix" OR "acellular dermis" OR "extracellular matrix")Condition:(skin OR rejuvenation OR wrinkles OR "skin quality" OR photoaging)run it → · recruiting only →
Hyaluronic acid fillerInjectables · 1,298 PubMed (1,033 in 10 years) · 46 registered, 3 recruiting
Products in the index using this technique: Belotero Balance, Belotero Intense (+) Lidocaine, Belotero Volume (+) Lidocaine, Juvederm Ultra XC, Juvederm Volbella XC, Juvederm Vollure XC, Juvederm Voluma XC, Juvederm Volux XC, Profhilo, RHA Collection, Restylane Defyne, Restylane Kysse, Restylane Lyft, Restylane Silk, Revanesse Versa, SKINVIVE by Juvederm. Query set v1-2026-07-25.
- PubMed, all time — 1,298 records
("hyaluronic acid filler"[tiab] OR "hyaluronic acid dermal filler"[tiab] OR ("hyaluronic acid"[tiab] AND ("dermal filler"[tiab] OR "soft tissue filler"[tiab] OR "nasolabial"[tiab] OR "lip augmentation"[tiab] OR "midface"[tiab]))) AND (aesthetic[tiab] OR cosmetic[tiab] OR facial[tiab] OR skin[tiab] OR volume[tiab])run this query on PubMed →- PubMed, 10-year window — 1,033 records
("hyaluronic acid filler"[tiab] OR "hyaluronic acid dermal filler"[tiab] OR ("hyaluronic acid"[tiab] AND ("dermal filler"[tiab] OR "soft tissue filler"[tiab] OR "nasolabial"[tiab] OR "lip augmentation"[tiab] OR "midface"[tiab]))) AND (aesthetic[tiab] OR cosmetic[tiab] OR facial[tiab] OR skin[tiab] OR volume[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 46 registered, 3 recruiting on the fetch date
- Intervention:
("hyaluronic acid filler" OR "hyaluronic acid dermal filler" OR "HA filler")Condition:("nasolabial folds" OR "facial wrinkles" OR "lip augmentation" OR "volume deficit" OR cosmetic)run it → · recruiting only →
PDLLA / PLLA collagen biostimulatorInjectables · 450 PubMed (336 in 10 years) · 49 registered, 6 recruiting
Products in the index using this technique: AestheFill. Query set v2-2026-08-02.
- PubMed, all time — 450 records
("poly-D,L-lactic acid"[tiab] OR "poly-L-lactic acid"[tiab] OR "polylactic acid"[tiab] OR "PDLLA"[tiab] OR "PLLA"[tiab]) AND (filler*[tiab] OR biostimulat*[tiab] OR collagen[tiab]) AND (skin[tiab] OR facial[tiab] OR aesthetic*[tiab] OR rejuvenation[tiab])run this query on PubMed →- PubMed, 10-year window — 336 records
("poly-D,L-lactic acid"[tiab] OR "poly-L-lactic acid"[tiab] OR "polylactic acid"[tiab] OR "PDLLA"[tiab] OR "PLLA"[tiab]) AND (filler*[tiab] OR biostimulat*[tiab] OR collagen[tiab]) AND (skin[tiab] OR facial[tiab] OR aesthetic*[tiab] OR rejuvenation[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 49 registered, 6 recruiting on the fetch date
- Intervention:
("poly-L-lactic acid" OR "polylactic acid" OR "PLLA" OR "Sculptra")Condition:(skin OR wrinkles OR rejuvenation OR "facial volume" OR photoaging)run it → · recruiting only →
Poly-L-lactic acid collagen stimulatorInjectables · 586 PubMed (371 in 10 years) · 17 registered, 0 recruiting
Products in the index using this technique: Sculptra. Query set v1-2026-07-25.
- PubMed, all time — 586 records
("poly-L-lactic acid"[tiab] OR "polylactic acid"[tiab] OR "PLLA"[tiab]) AND (facial[tiab] OR aesthetic[tiab] OR cosmetic[tiab] OR "dermal filler"[tiab] OR lipoatrophy[tiab] OR "collagen stimulat"[tiab] OR nasolabial[tiab])run this query on PubMed →- PubMed, 10-year window — 371 records
("poly-L-lactic acid"[tiab] OR "polylactic acid"[tiab] OR "PLLA"[tiab]) AND (facial[tiab] OR aesthetic[tiab] OR cosmetic[tiab] OR "dermal filler"[tiab] OR lipoatrophy[tiab] OR "collagen stimulat"[tiab] OR nasolabial[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 17 registered, 0 recruiting on the fetch date
- Intervention:
("poly-L-lactic acid" OR "injectable poly-L-lactic acid")Condition:("facial lipoatrophy" OR "nasolabial folds" OR "facial wrinkles" OR cellulite OR cosmetic)run it → · recruiting only →
Polynucleotide (PDRN) skin boosterInjectables · 155 PubMed (121 in 10 years) · 16 registered, 2 recruiting
Products in the index using this technique: Rejuran. Query set v2-2026-08-02.
- PubMed, all time — 155 records
("polynucleotide"[tiab] OR "polydeoxyribonucleotide"[tiab] OR "PDRN"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR dermal[tiab] OR rejuvenation[tiab] OR aesthetic*[tiab])run this query on PubMed →- PubMed, 10-year window — 121 records
("polynucleotide"[tiab] OR "polydeoxyribonucleotide"[tiab] OR "PDRN"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR dermal[tiab] OR rejuvenation[tiab] OR aesthetic*[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 16 registered, 2 recruiting on the fetch date
- Intervention:
("polynucleotide" OR "polydeoxyribonucleotide" OR "PDRN" OR "Rejuran")Condition:(skin OR rejuvenation OR wrinkles OR erythema OR photoaging OR "skin quality")run it → · recruiting only →
Ablative / hybrid fractional laserLasers & Light · 1,485 PubMed (940 in 10 years) · 229 registered, 13 recruiting
Products in the index using this technique: AcuPulse, Alma Hybrid, CO2RE, Halo, SP Dynamis, SmartXide, UltraPulse, eCO2. Query set v1-2026-07-25.
- PubMed, all time — 1,485 records
("ablative fractional"[tiab] OR "fractional CO2"[tiab] OR "fractional carbon dioxide"[tiab] OR "fractional erbium"[tiab] OR "erbium:YAG"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR resurfacing[tiab] OR wrinkle*[tiab] OR scar*[tiab] OR rejuvenation[tiab])run this query on PubMed →- PubMed, 10-year window — 940 records
("ablative fractional"[tiab] OR "fractional CO2"[tiab] OR "fractional carbon dioxide"[tiab] OR "fractional erbium"[tiab] OR "erbium:YAG"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR resurfacing[tiab] OR wrinkle*[tiab] OR scar*[tiab] OR rejuvenation[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 229 registered, 13 recruiting on the fetch date
- Intervention:
("ablative fractional laser" OR "fractional CO2 laser" OR "carbon dioxide laser" OR "erbium YAG laser")Condition:(skin OR wrinkles OR scars OR photoaging OR rejuvenation OR resurfacing)run it → · recruiting only →
IPL / broadband lightLasers & Light · 1,028 PubMed (488 in 10 years) · 43 registered, 5 recruiting
Products in the index using this technique: BBL, Harmony XL, Icon, Nordlys, Stellar M22. Query set v1-2026-07-25.
- PubMed, all time — 1,028 records
("intense pulsed light"[tiab] OR "broadband light"[tiab] OR IPL[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR photoaging[tiab] OR rosacea[tiab] OR pigmentation[tiab] OR rejuvenation[tiab] OR "hair removal"[tiab])run this query on PubMed →- PubMed, 10-year window — 488 records
("intense pulsed light"[tiab] OR "broadband light"[tiab] OR IPL[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR photoaging[tiab] OR rosacea[tiab] OR pigmentation[tiab] OR rejuvenation[tiab] OR "hair removal"[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 43 registered, 5 recruiting on the fetch date
- Intervention:
("intense pulsed light" OR "broadband light" OR IPL)Condition:(skin OR photoaging OR rosacea OR pigmentation OR rejuvenation OR hirsutism)run it → · recruiting only →
Laser hair removalLasers & Light · 744 PubMed (359 in 10 years) · 30 registered, 1 recruiting
Products in the index using this technique: Apogee Elite, Clarity II, Diolaze, Elite iQ, GentleLase, GentleMax Pro, LightSheer, Motus, Soprano, Splendor X, Vectus. Query set v1-2026-07-25.
- PubMed, all time — 744 records
("laser hair removal"[tiab] OR "laser epilation"[tiab] OR "photoepilation"[tiab] OR ("alexandrite"[tiab] AND hair[tiab]) OR ("diode laser"[tiab] AND "hair removal"[tiab])) AND (skin[tiab] OR hair[tiab] OR cutaneous[tiab])run this query on PubMed →- PubMed, 10-year window — 359 records
("laser hair removal"[tiab] OR "laser epilation"[tiab] OR "photoepilation"[tiab] OR ("alexandrite"[tiab] AND hair[tiab]) OR ("diode laser"[tiab] AND "hair removal"[tiab])) AND (skin[tiab] OR hair[tiab] OR cutaneous[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 30 registered, 1 recruiting on the fetch date
- Intervention:
("laser hair removal" OR "laser epilation" OR photoepilation OR "alexandrite laser" OR "diode laser hair")Condition:(hirsutism OR "unwanted hair" OR "hair removal" OR pseudofolliculitis OR skin)run it → · recruiting only →
Non-ablative fractional laserLasers & Light · 1,157 PubMed (742 in 10 years) · 128 registered, 10 recruiting
Products in the index using this technique: Clear + Brilliant, Frax, Fraxel, LaseMD. Query set v1-2026-07-25.
- PubMed, all time — 1,157 records
("nonablative fractional"[tiab] OR "non-ablative fractional"[tiab] OR "fractional photothermolysis"[tiab] OR "fractional laser"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR wrinkle*[tiab] OR rhytid*[tiab] OR scar*[tiab] OR photoaging[tiab] OR rejuvenation[tiab])run this query on PubMed →- PubMed, 10-year window — 742 records
("nonablative fractional"[tiab] OR "non-ablative fractional"[tiab] OR "fractional photothermolysis"[tiab] OR "fractional laser"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR wrinkle*[tiab] OR rhytid*[tiab] OR scar*[tiab] OR photoaging[tiab] OR rejuvenation[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 128 registered, 10 recruiting on the fetch date
- Intervention:
("nonablative fractional laser" OR "fractional photothermolysis" OR "fractional laser")Condition:(skin OR wrinkles OR scars OR photoaging OR rejuvenation OR melasma)run it → · recruiting only →
Picosecond laser (pigment & tattoo)Lasers & Light · 323 PubMed (306 in 10 years) · 27 registered, 0 recruiting
Products in the index using this technique: Discovery Pico, PicoCare, PicoPlus, PicoSure, PicoWay, enlighten. Query set v1-2026-07-25.
- PubMed, all time — 323 records
("picosecond laser"[tiab] OR "picosecond-domain"[tiab] OR "pico laser"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR tattoo*[tiab] OR pigment*[tiab] OR melasma[tiab] OR lentig*[tiab] OR rejuvenation[tiab])run this query on PubMed →- PubMed, 10-year window — 306 records
("picosecond laser"[tiab] OR "picosecond-domain"[tiab] OR "pico laser"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR tattoo*[tiab] OR pigment*[tiab] OR melasma[tiab] OR lentig*[tiab] OR rejuvenation[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 27 registered, 0 recruiting on the fetch date
- Intervention:
("picosecond laser")Condition:(tattoo OR melasma OR pigmentation OR lentigines OR acne scars OR skin)run it → · recruiting only →
Pulsed dye laserLasers & Light · 1,530 PubMed (613 in 10 years) · 72 registered, 3 recruiting
Products in the index using this technique: Cynergy, Vbeam. Query set v1-2026-07-25.
- PubMed, all time — 1,530 records
("pulsed dye laser"[tiab] OR "pulsed-dye laser"[tiab] OR "595 nm"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR "port wine"[tiab] OR telangiectas*[tiab] OR rosacea[tiab] OR scar*[tiab] OR vascular[tiab])run this query on PubMed →- PubMed, 10-year window — 613 records
("pulsed dye laser"[tiab] OR "pulsed-dye laser"[tiab] OR "595 nm"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR "port wine"[tiab] OR telangiectas*[tiab] OR rosacea[tiab] OR scar*[tiab] OR vascular[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 72 registered, 3 recruiting on the fetch date
- Intervention:
("pulsed dye laser")Condition:("port wine stain" OR rosacea OR telangiectasia OR hemangioma OR scars OR skin)run it → · recruiting only →
Sebaceous-gland laser for acneLasers & Light · 66 PubMed (40 in 10 years) · 5 registered, 1 recruiting
Products in the index using this technique: Accure, AviClear. Query set v1-2026-07-25.
- PubMed, all time — 66 records
(("1726 nm"[tiab] OR "1,726 nm"[tiab] OR "sebaceous gland"[tiab] OR "sebum suppression"[tiab]) AND laser[tiab]) AND (acne[tiab] OR skin[tiab] OR cutaneous[tiab])run this query on PubMed →- PubMed, 10-year window — 40 records
(("1726 nm"[tiab] OR "1,726 nm"[tiab] OR "sebaceous gland"[tiab] OR "sebum suppression"[tiab]) AND laser[tiab]) AND (acne[tiab] OR skin[tiab] OR cutaneous[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 5 registered, 1 recruiting on the fetch date
- Intervention:
("1726 nm laser" OR "sebaceous gland laser" OR "laser treatment of acne")Condition:("acne vulgaris" OR acne OR skin)run it → · recruiting only →
Mechanical microneedlingRF & Microneedling · 619 PubMed (564 in 10 years) · 135 registered, 13 recruiting
Products in the index using this technique: MicroPen EVO, Rejuvapen NXT, SkinPen, SkinStylus, ellacor. Query set v1-2026-07-25.
- PubMed, all time — 619 records
("microneedling"[tiab] OR "micro-needling"[tiab] OR "percutaneous collagen induction"[tiab] OR "dermaroller"[tiab] OR "dermapen"[tiab]) NOT ("radiofrequency"[tiab] OR "microneedle patch"[tiab] OR "vaccine"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR scar*[tiab] OR wrinkle*[tiab] OR rejuvenation[tiab])run this query on PubMed →- PubMed, 10-year window — 564 records
("microneedling"[tiab] OR "micro-needling"[tiab] OR "percutaneous collagen induction"[tiab] OR "dermaroller"[tiab] OR "dermapen"[tiab]) NOT ("radiofrequency"[tiab] OR "microneedle patch"[tiab] OR "vaccine"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR scar*[tiab] OR wrinkle*[tiab] OR rejuvenation[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 135 registered, 13 recruiting on the fetch date
- Intervention:
(microneedling OR "percutaneous collagen induction" OR dermaroller)Condition:("acne scars" OR scars OR skin OR wrinkles OR rejuvenation OR melasma)run it → · recruiting only →
Monopolar RF skin tighteningRF & Microneedling · 432 PubMed (293 in 10 years) · 9 registered, 1 recruiting
Products in the index using this technique: TempSure, Thermage, Volnewmer. Query set v1-2026-07-25.
- PubMed, all time — 432 records
("monopolar radiofrequency"[tiab] OR "radiofrequency tightening"[tiab] OR ("radiofrequency"[tiab] AND "skin laxity"[tiab]) OR ("radiofrequency"[tiab] AND "skin tightening"[tiab])) AND (skin[tiab] OR cutaneous[tiab] OR face[tiab] OR facial[tiab])run this query on PubMed →- PubMed, 10-year window — 293 records
("monopolar radiofrequency"[tiab] OR "radiofrequency tightening"[tiab] OR ("radiofrequency"[tiab] AND "skin laxity"[tiab]) OR ("radiofrequency"[tiab] AND "skin tightening"[tiab])) AND (skin[tiab] OR cutaneous[tiab] OR face[tiab] OR facial[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 9 registered, 1 recruiting on the fetch date
- Intervention:
("monopolar radiofrequency" OR "radiofrequency skin tightening")Condition:("skin laxity" OR wrinkles OR skin OR rejuvenation OR cellulite)run it → · recruiting only →
Radiofrequency microneedlingRF & Microneedling · 354 PubMed (304 in 10 years) · 37 registered, 1 recruiting
Products in the index using this technique: Agnes RF, EndyMed Intensif, Fractora, Genius, INTRAcel, Infini, Morpheus8, Potenza, Profound, Scarlet SRF, Secret Pro, Secret RF, Sylfirm X, Venus Viva, VirtueRF, Vivace. Query set v1-2026-07-25.
- PubMed, all time — 354 records
("radiofrequency microneedling"[tiab] OR "microneedle radiofrequency"[tiab] OR "fractional radiofrequency"[tiab] OR "microneedling radiofrequency"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR wrinkle*[tiab] OR rhytid*[tiab] OR scar*[tiab] OR laxity[tiab] OR rejuvenation[tiab])run this query on PubMed →- PubMed, 10-year window — 304 records
("radiofrequency microneedling"[tiab] OR "microneedle radiofrequency"[tiab] OR "fractional radiofrequency"[tiab] OR "microneedling radiofrequency"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR wrinkle*[tiab] OR rhytid*[tiab] OR scar*[tiab] OR laxity[tiab] OR rejuvenation[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 37 registered, 1 recruiting on the fetch date
- Intervention:
("radiofrequency microneedling" OR "microneedle radiofrequency" OR "fractional radiofrequency")Condition:(skin OR wrinkles OR "acne scars" OR "skin laxity" OR rejuvenation)run it → · recruiting only →
Bimatoprost for eyelash growthSkin & Topicals · 128 PubMed (52 in 10 years) · 28 registered, 0 recruiting
Products in the index using this technique: Latisse. Query set v1-2026-07-25.
- PubMed, all time — 128 records
(bimatoprost[tiab] OR "prostaglandin analog"[tiab]) AND (eyelash*[tiab] OR hypotrichosis[tiab] OR "lash growth"[tiab])run this query on PubMed →- PubMed, 10-year window — 52 records
(bimatoprost[tiab] OR "prostaglandin analog"[tiab]) AND (eyelash*[tiab] OR hypotrichosis[tiab] OR "lash growth"[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 28 registered, 0 recruiting on the fetch date
- Intervention:
(bimatoprost)Condition:("eyelash hypotrichosis" OR eyelashes OR hypotrichosis OR cosmetic)run it → · recruiting only →
HydradermabrasionSkin & Topicals · 166 PubMed (73 in 10 years) · 9 registered, 0 recruiting
Products in the index using this technique: HydraFacial. Query set v1-2026-07-25.
- PubMed, all time — 166 records
(hydradermabrasion[tiab] OR "hydrafacial"[tiab] OR "hydro-dermabrasion"[tiab] OR ("microdermabrasion"[tiab] AND skin[tiab])) AND (skin[tiab] OR facial[tiab] OR acne[tiab] OR rejuvenation[tiab] OR photoaging[tiab])run this query on PubMed →- PubMed, 10-year window — 73 records
(hydradermabrasion[tiab] OR "hydrafacial"[tiab] OR "hydro-dermabrasion"[tiab] OR ("microdermabrasion"[tiab] AND skin[tiab])) AND (skin[tiab] OR facial[tiab] OR acne[tiab] OR rejuvenation[tiab] OR photoaging[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 9 registered, 0 recruiting on the fetch date
- Intervention:
(hydradermabrasion OR hydrafacial OR microdermabrasion)Condition:(skin OR acne OR "facial rejuvenation" OR photoaging OR cosmetic)run it → · recruiting only →
Topical clascoteroneSkin & Topicals · 90 PubMed (88 in 10 years) · 21 registered, 2 recruiting
Products in the index using this technique: Winlevi. Query set v1-2026-07-25.
- PubMed, all time — 90 records
(clascoterone[tiab] OR "cortexolone 17"[tiab] OR "androgen receptor inhibitor"[tiab]) AND (acne[tiab] OR skin[tiab] OR cutaneous[tiab] OR "androgenetic alopecia"[tiab])run this query on PubMed →- PubMed, 10-year window — 88 records
(clascoterone[tiab] OR "cortexolone 17"[tiab] OR "androgen receptor inhibitor"[tiab]) AND (acne[tiab] OR skin[tiab] OR cutaneous[tiab] OR "androgenetic alopecia"[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 21 registered, 2 recruiting on the fetch date
- Intervention:
(clascoterone OR "cortexolone 17 alpha-propionate")Condition:("acne vulgaris" OR acne OR "androgenetic alopecia" OR skin)run it → · recruiting only →
Topical hydroquinone / triple combinationSkin & Topicals · 1,116 PubMed (509 in 10 years) · 51 registered, 4 recruiting
Products in the index using this technique: Tri-Luma. Query set v1-2026-07-25.
- PubMed, all time — 1,116 records
(hydroquinone[tiab] OR "triple combination cream"[tiab] OR "fluocinolone acetonide"[tiab]) AND (melasma[tiab] OR "hyperpigmentation"[tiab] OR "post-inflammatory hyperpigmentation"[tiab] OR skin[tiab] OR "skin lightening"[tiab])run this query on PubMed →- PubMed, 10-year window — 509 records
(hydroquinone[tiab] OR "triple combination cream"[tiab] OR "fluocinolone acetonide"[tiab]) AND (melasma[tiab] OR "hyperpigmentation"[tiab] OR "post-inflammatory hyperpigmentation"[tiab] OR skin[tiab] OR "skin lightening"[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 51 registered, 4 recruiting on the fetch date
- Intervention:
(hydroquinone OR "triple combination cream")Condition:(melasma OR hyperpigmentation OR "skin pigmentation" OR skin)run it → · recruiting only →
Topical retinoidSkin & Topicals · 4,253 PubMed (1,332 in 10 years) · 343 registered, 14 recruiting
Products in the index using this technique: Aklief, Differin, Renova, Retin-A, Tazorac. Query set v1-2026-07-25.
- PubMed, all time — 4,253 records
("topical tretinoin"[tiab] OR "topical retinoid"[tiab] OR "retinoic acid"[tiab] OR adapalene[tiab] OR tazarotene[tiab] OR "retinol"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR acne[tiab] OR photoaging[tiab] OR wrinkle*[tiab] OR melasma[tiab])run this query on PubMed →- PubMed, 10-year window — 1,332 records
("topical tretinoin"[tiab] OR "topical retinoid"[tiab] OR "retinoic acid"[tiab] OR adapalene[tiab] OR tazarotene[tiab] OR "retinol"[tiab]) AND (skin[tiab] OR cutaneous[tiab] OR acne[tiab] OR photoaging[tiab] OR wrinkle*[tiab] OR melasma[tiab]) AND ("2016/01/01"[dp] : "2026/12/31"[dp])run the windowed query →- ClinicalTrials.gov — 343 registered, 14 recruiting on the fetch date
- Intervention:
(tretinoin OR "topical retinoid" OR adapalene OR tazarotene OR retinol)Condition:("acne vulgaris" OR photoaging OR "facial wrinkles" OR melasma OR skin)run it → · recruiting only →
Crosswalk
FDA does not index its databases by marketing name. A clinic buys a Morpheus8; FDA cleared a record whose device name happens to contain that word. Connecting the two is the single most error-prone step on this site, so the rule is narrow and it is published.
| Rule | Text |
|---|---|
| Crosswalk | A brand is marked 'verified' only when an FDA record's own name field contains the brand token (and, where a manufacturer hint was used, the applicant field contains it too). Anything else is 'unverified' with null regulatory fields. No K-number, PMA number or date in this file was inferred. |
| Language | 510(k) records are described as CLEARED. PMA and BLA/NDA records are described as APPROVED. The 'pathway' and 'regulatory_verb' fields carry this so the UI cannot get it wrong. |
A curated seed list of widely used medical-aesthetic products, each crosswalked to a real FDA record where one could be found with confidence. Inclusion here is NOT an endorsement, NOT a ranking, and NOT a claim of market share. Absence is not a judgement -- it means it is not in this seed list yet.
| Pathway | Products |
|---|---|
| 510(k) | 90 |
| BLA | 7 |
| NDA | 10 |
| PMA | 18 |
| Unresolved product | Why |
|---|---|
| Emsculpt NEO | No openFDA 510(k) record carries this brand name in its device_name field. Many platforms are cleared under an internal system or model name rather than the marketing name, so a K-number cannot be assigned without guessing. Left null on purpose. |
| AestheFill | Searched openFDA for a 510(k), a PMA and a drug-label record under this brand name; all three returned zero results on the run date, as did an applicant search for Regen Biotech. A distributor-run brand site describes AestheFill as an 'FDA approved substance' under a GRAS (Generally Recognized as Safe) registration. GRAS is a food-additive concept and is not a device clearance or a device approval, and no FDA clearance or approval record exists for AestheFill. The claim is noted here because a reader is likely to meet it, not because it corresponds to an FDA record. |
| ASCE+ | Searched openFDA for a 510(k), a PMA and a drug-label record under this brand name on the run date; all three returned zero results, as did an applicant search for ExoCoBio. The maker publishes facility and quality-system certifications, including an MFDS GMP certification for medical-device manufacturing and ISO 13485. Those certify a facility and a quality system; they are not approvals of this product. |
| CellREDM | Searched openFDA for a 510(k), a PMA and a drug-label record under this brand name; all three returned zero results on the run date. Its maker, Hans Biomed Corporation, does hold eight US 510(k) clearances for other products, so the absence here is not an absence of FDA experience on the company's part. This particular product has no US record. |
| Ellansé | Searched openFDA for a PMA or 510(k) record under this trade name and under the manufacturer's name; both trade-name searches returned NOT_FOUND and the applicant searches returned only unrelated Sinclair Pharmaceuticals oral/wound products. No US regulatory number is assigned. Absence of a record here is not proof of anything beyond: openFDA has no matching record on the run date. Re-checked on the current run date: the 510(k), PMA and drug-label searches still return zero results, so this is a checked absence rather than an unmatched crosswalk. |
| Elravie Re2O | Searched openFDA for a 510(k), a PMA and a drug-label record under this brand name; all three returned zero results on the run date, as did the same searches for 'Re2O' alone and applicant searches for L&C Bio and Humedix. The product is made by L&C Bio Co., Ltd. and distributed in South Korea by Humedix under the Elravie brand, so the two companies play different roles; the rest of the Elravie line is crosslinked hyaluronic acid and is a different kind of product. L&C Bio lists Re2O under human tissue rather than under medical devices. |
| Juveacell | Searched openFDA for a 510(k), a PMA and a drug-label record under this brand name on the run date; all three returned zero results. The product's own site names VAIM Co., Ltd. of Daejeon, South Korea as the company behind it and DOF as the tissue bank. A claim repeated on clinic sites that Juveacell is made by a company called ESSALIA could not be substantiated against any company or regulator record and contradicts the product's own site, so it is not repeated here. |
| Profhilo | Searched openFDA for a PMA or 510(k) record under this trade name and under the manufacturer's name; both trade-name searches returned NOT_FOUND and the applicant searches returned only unrelated IBSA products (viscosupplements, a hydrocolloid dressing). No US regulatory number is assigned. Absence of a record here is not proof of anything beyond: openFDA has no matching record on the run date. Re-checked on the current run date: the 510(k), PMA and drug-label searches still return zero results, so this is a checked absence rather than an unmatched crosswalk. |
| Rejuran | Searched openFDA for a 510(k), a PMA and a drug-label record under this brand name; all three returned zero results on the run date. An applicant search for 'Pharma Research' returns a single 510(k), but it belongs to Apr Applied Pharma Research SA, an unrelated Swiss company, and is not counted as a match. Rejuran is sold in South Korea. No MFDS licence identifier could be obtained at citation grade: the MFDS device database requires a session and refused every query, and the licence number circulating on aggregator sites could not be traced to an official record, so none is published here. |
| Halo | No openFDA 510(k) record carries this brand name in its device_name field. Many platforms are cleared under an internal system or model name rather than the marketing name, so a K-number cannot be assigned without guessing. Left null on purpose. |
| HydraFacial | No openFDA 510(k) record carries this brand name in its device_name field. Many platforms are cleared under an internal system or model name rather than the marketing name, so a K-number cannot be assigned without guessing. Left null on purpose. |
The crosswalk maps a marketing name to FDA records whose own name field contains that name. It is a name match, not a legal statement about which entity holds which clearance, and it can be wrong in both directions: a platform cleared under an internal model number will be missed, and a manufacturer that reuses a word across product lines can pull in a record that belongs to a sibling product. Every card on this site prints the identifier it matched so you can check it in one click.
Two dating caveats that follow from the source records
For drug products the first decision date is the original approval, which can predate the cosmetic indication by decades — Drugs@FDA exposes no per-indication dates, so none is claimed.
Where a PMA product has no original record under its trade name and was added by supplement, the earliest matched supplement date is shown and labelled as such rather than being presented as an original approval.
Found an error in a crosswalk? That is the most useful mail this project gets. Write to damini@automationcoreinc.com with the product and the identifier you think is wrong.
EUDAMED
EUDAMED is the European Database on Medical Devices, run by the European Commission. Its public search has an unauthenticated JSON API, and this Index asks it one narrow question per product: is there a device record whose trade name and whose legal manufacturer both correspond to this product? When the answer is yes, the product page shows the record and links to it.
When the answer is no, the product page shows nothing. Not a dash, not a grey badge, not a “not found”. This is the whole point of the section and it is worth being blunt about: EUDAMED device registration only became mandatory on 28 May 2026, with a transition period running to 28 November 2026. A product this Index could not match today may be fully CE marked and on sale across the EU. Absence from EUDAMED is not a fact about a device, so this Index refuses to draw it.
A EUDAMED entry is a registration. It is not an FDA-style clearance or approval, it is not a Notified Body certificate, and it says nothing about safety, efficacy or quality. Where EUDAMED states a risk class or a market status, that is EUDAMED’s own field, copied across unchanged.
| What | Endpoint or rule |
|---|---|
| Device search | https://ec.europa.eu/tools/eudamed/api/devices/udiDiData?page={page}&pageSize={page_size}&size={page_size}&languageIso2Code=en&iso2Code=en&{filter} |
| Device record | https://ec.europa.eu/tools/eudamed/api/devices/udiDiData/{uuid}?languageIso2Code=en&iso2Code=en |
| Manufacturer (actor) search | https://ec.europa.eu/tools/eudamed/api/eos?page={page}&pageSize={page_size}&size={page_size}&languageIso2Code=en&iso2Code=en&name={name} |
| Public record link | https://ec.europa.eu/tools/eudamed/#/screen/search-device/{uuid} |
| Authentication | none - unauthenticated GET, JSON, no key, no cookie |
| Filters the server accepts | tradeName, deviceModel, name, basicUdi, primaryDi, reference, srn, riskClassCode, deviceStatusCode, deviceScopes, includeHistoricalVersion, medicalPurposeProcedurePack |
| Filters it does not | Silently ignored - the server returns the entire corpus. This script raises rather than trusting any response of that size. |
The matching rule
A match is confirmed only when BOTH the EUDAMED trade name contains our brand as a whole token run AND the EUDAMED legal manufacturer corresponds to our manufacturer string or to an FDA applicant string fetched for that device - after stripping corporate suffixes, or via one of the corporate relationships recorded in 'corporate_groups' below. Everything weaker is unmatched.
Both halves are required, and the manufacturer half is what does the real work. Searching EUDAMED for “Botox” returns a “Botox & Filler Injection Pack” filed by an unrelated Irish company; searching for “BBL” returns Becton Dickinson’s microbiology line. Neither passes the manufacturer test, so neither appears anywhere on this site. A false positive here would put a European registration under the wrong product name, which is worse than showing nothing — so when the two halves disagree, the Index shows nothing.
| Names treated as one company | Why |
|---|---|
| solta medical, bausch health, valeant | Solta Medical is a Bausch Health company (formerly Valeant). |
| ulthera, merz, merz north america, merz pharma, merz pharmaceuticals, merz aesthetics | Merz acquired Ulthera; Merz North America and Merz Pharma are Merz group entities. |
| zeltiq aesthetics, zeltiq, allergan, abbvie, allergan aesthetics | Allergan acquired ZELTIQ (CoolSculpting); Allergan is an AbbVie company. |
| cynosure, cynosure lutronic, lutronic, lutronic global, hologic, palomar medical technologies, palomar medical | Cynosure acquired Palomar; Cynosure was a Hologic division; Cynosure and Lutronic merged as Cynosure Lutronic. |
| inmode, inmode md, invasix | InMode was founded and formerly traded as Invasix. |
| syneron, syneron medical, candela, syneron candela, syneron-candela | Syneron and Candela merged as Syneron Candela, now Candela. |
| q-med, q med, galderma, galderma labs, galderma laboratories | Q-Med AB (Restylane, Sculptra) is a Galderma company. |
| el en, el.en, deka, deka mela, deka m e l a | DEKA M.E.L.A. is the medical-laser company of the El.En. group. |
| crown aesthetics, bellus medical, crown laboratories | SkinPen moved from Bellus Medical to Crown Aesthetics (Crown Laboratories). |
| tiger aesthetics medical, tiger aesthetics, suneva medical | Bellafill moved from Suneva Medical to Tiger Aesthetics Medical. |
| lumenis, lumenis be | Lumenis Be Ltd. is the Lumenis legal entity. |
| alma lasers, alma | Alma Lasers Inc. (US) and Alma Lasers Ltd. (Israel) are the same group. |
| eclipse medcorp, eclipse aesthetics, eclipse med | Eclipse Medcorp trades as Eclipse Aesthetics. |
| venus concept, venus concept usa | Venus Concept USA Inc. is the US entity of Venus Concept. |
| endymed medical, endymed | Same company, spelling varies. |
| ipsen biopharm, ipsen, galderma | Dysport is manufactured by Ipsen; Galderma distributes it in some markets. |
| sun pharmaceutical industries, sun pharm, sun pharma, dusa pharmaceuticals | DUSA Pharmaceuticals (BLU-U) is a Sun Pharmaceutical company. |
| kenvue brands, kenvue, johnson johnson consumer | Kenvue is the former Johnson & Johnson consumer-health business. |
| halozyme therap, halozyme, halozyme therapeutics | Same company, truncated in the FDA record. |
| led intellectual properties, lightstim | LightStim devices are held by LED Intellectual Properties LLC. |
| biophotas, celluma | Biophotas trades as Celluma. |
| globalmed technologies, omnilux | GlobalMed Technologies markets Omnilux. |
| esthetic medical, skinstylus | SkinStylus is made by Esthetic Medical Inc. |
| refine, refine usa | Same company, spelling varies. |
| merz pharms, merz | FDA writes 'MERZ PHARMS' for Merz Pharmaceuticals. |
| almirall, almirall llc | Same company. |
| johari digital healthcare, cutera | Johari Digital Healthcare is the contract manufacturer named on Cutera's truSculpt flex FDA record. |
| zimmer medizinsysteme, zimmer medizinsystems, zeltiq aesthetics, allergan | Zimmer MedizinSysteme is the named manufacturer on Allergan/ZELTIQ's CoolTone FDA record. |
| bios, lumenis, lumenis be | Bios S.R.L. is the Italian manufacturer named on Lumenis-marketed NuEra/Splendor FDA records. |
| ilooda, cutera | Ilooda Co., Ltd. manufactures the Secret RF / Secret Pro platforms distributed by Cutera. |
| jeisys medical, jeisys | Same company, spelling varies. |
| Product | Name in EUDAMED | Manufacturer in EUDAMED | Basic UDI-DI | Risk class | Link |
|---|---|---|---|---|---|
| Accent | Accent Prime | Alma Lasers GmbH | 42520046ACCENTPRIMEWC | Class IIb | Record → |
| AcuPulse | AcuPulse™ | Lumenis (Germany) GmbH | 426053918ACPES | Class IIb | Record → |
| Alma Hybrid | Alma Hybrid | Alma Lasers GmbH | 42520046ALMAHYBRIDDW | Class IIb | Record → |
| AviClear | AviClear | Cutera, Inc. | 00816722021700DH | Class IIb | Record → |
| Cellulaze | ThermaGuide Cannula for Cellulaze, 250mm | Cynosure LLC | B-00841494100469 | Class IIa | Record → |
| Celluma | Celluma | BioPhotas, Inc. | B-00850523007082 | Class IIa | Record → |
| Clarity II | CLARITY II (ICD Type) | Lutronic Corporation | 88094476511102AVK | Class IIb | Record → |
| Clear + Brilliant | Clear+Brilliant® Laser System | Solta Medical, Inc. | B-00850608002636 | Class IIb | Record → |
| CoolSculpting Elite | CoolSculpting Elite Control Unit | Zeltiq Aesthetics, Inc. | 0816417020001SL | Class IIb | Record → |
| Cynergy | Cynergy | Cynosure LLC | B-00841494100087 | Class IIb | Record → |
| Discovery Pico | Discovery Pico | Quanta System S.p.A. | B-08059173391011 | Class IIb | Record → |
| enlighten | enlighten SR | Cutera, Inc. | 00816722021600DC | Class IIb | Record → |
| Frax | Frax Pro | Candela Corporation | B-00817495023465 | Class IIb | Record → |
| Fraxel | Fraxel | Solta Medical, Inc. | 081699502B0006WE | Class I | Record → |
| Genius | LUTRONIC GENIUS body | Lutronic Corporation | 88094476511007AVT | Class IIb | Record → |
| GentleLase | GentleLASE Pro-U | Candela Corporation | B-00817495020082 | Class IIb | Record → |
| GentleMax Pro | GentleMax Pro Medium DCD HP | Candela Corporation | B-00817495024592 | Class IIb | Record → |
| Hollywood Spectra | HOLLYWOOD SPECTRA | Cynosure Lutronic Technology Corporation | 88002918210118AHE | Class IIb | Record → |
| Icon | Icon | Cynosure LLC | B-00841494100018 | Class IIb | Record → |
| LaseMD | LaseMD Ultra Laser System main body (Including Fiber and Handpiece) | Lutronic Corporation | 88094476511202AVS | Class IIb | Record → |
| LightSheer | LightSheer® QUATTRO™ | Lumenis Be LTD | 729011777LSUW | Class IIb | Record → |
| LightStim | LightStim Elipsa | LED Intellectual Properties | 0850030819LightstimDG | Class IIb | Record → |
| Morpheus8 | Morpheus8 Burst applicator by Ignite RF | InMode ltd. | 7290016633AG613055x4X | Class IIb | Record → |
| Motus | MOTUS AZ | DEKA M.E.L.A. SRL | B-08034108512341 | Class IIb | Record → |
| Nordlys | Nordlys System | Candela Corporation | B-00817495023434 | Class IIb | Record → |
| NuEra Tight | NuEra Tight | BIOS Srl | 805204950SKRFD4 | Class IIb | Record → |
| PicoSure | PicoSure | Cynosure LLC | B-00841494100001 | Class IIb | Record → |
| PicoWay | PicoWay Laser System | Candela Corporation | B-00817495021393 | Class IIb | Record → |
| Potenza | POTENZA | Jeisys Medical Inc. | B-08800020101785 | Class IIb | Record → |
| Restylane Defyne | Restylane Defyne | Q-Med AB | B-012095LM | Class III | Record → |
| Restylane Kysse | Restylane Kysse | Q-Med AB | B-012062L6 | Class III | Record → |
| Restylane Lyft | Restylane Lyft Lidocaine | Q-Med AB | B-012129LD | Class III | Record → |
| RevLite | Revlite | Cynosure LLC | B-00841494100216 | Class IIb | Record → |
| Sculptra | Sculptra | Q-Med AB | B-084420P5 | Class III | Record → |
| SkinPen | SkinPen Precision | Crown Aesthetics | 08632210003SPPTKPM | Class IIa | Record → |
| SmartXide | SMARTXIDE | DEKA M.E.L.A. SRL | B-08034108510484 | Class IIb | Record → |
| Sofwave | Sofwave | Sofwave Medical Ltd. | B-07290018152003 | Class IIa | Record → |
| Soprano | Soprano Titanium | Alma Lasers GmbH | 42520046SOPRANOTITAN5Q | Class IIa | Record → |
| Splendor X | SPLENDOR X | BIOS Srl | 805204950LSRSPXHW | Class IIb | Record → |
| Stellar M22 | Stellar M22 RFX | Lumenis Be LTD | 729011777MAPL9 | Class IIb | Record → |
| Sylfirm X | SYLFIRM X | VIOL Medical Co., Ltd. | 880905233VIOLHFSUFXVF | Class IIb | Record → |
| TempSure | TempSure-RF System | Cynosure LLC | B-00841494107642 | Class IIb | Record → |
| Thermage | Thermage FLX System | Solta Medical, Inc. | 081699502B0014WD | Class I | Record → |
| truSculpt iD | truSculpt iD | Cutera, Inc. | B-00816722021427 | Class IIb | Record → |
| truSculpt | truSculpt 16 | Cutera, Inc. | B-00816722022448 | Class IIb | Record → |
| UltraPulse | UltraPulse® α | Lumenis Be LTD | 729011777UPAMY | Class IIb | Record → |
| Vbeam | VBeam Prima DCD Delivery system | Candela Corporation | B-00817495023014 | Class IIb | Record → |
| Vectus | Vectus | Cynosure LLC | B-00841494100124 | Class IIb | Record → |
| Vivace | VIVACE, VIVACE II | SHENB Co., Ltd. | 88000171SH004CA | Class IIb | Record → |
| Volnewmer | VOLNEWMER | CLASSYS | 8800016902693YC | Class IIb | Record → |
Listed in EUDAMED, the EU medical device database, as of 26 Jul 2026. EUDAMED registration became mandatory in May 2026 with a transition period, so devices not listed here may still be CE marked - we show only records we could match.
This file records presence, never absence. EUDAMED device registration became mandatory on 28 May 2026 with a transition period to 28 November 2026, so a device missing from EUDAMED may still be CE marked and on sale in the EU. A status of 'unmatched' means only that we could not match it. The site must render nothing at all for those devices - no dash, no grey badge, no empty state.
Manufacturer names
| Strings that collapse to the same company |
|---|
| ALLERGAN / Allergan |
| Candela Corp. / Candela Corporation |
| Cynosure / Cynosure, Inc. / Cynosure, LLC |
| Solta Medical / Solta Medical, Inc. |
Manufacturer counts on this site are counts of distinct applicant or sponsor strings as FDA printed them. They are not counts of companies, not counts of corporate groups, and not a measure of how many manufacturers serve the market.
Every manufacturer name on this site is the applicant or sponsor string printed on the FDA record. It is never retyped, never tidied up, and never replaced with the name a company uses in its own marketing. That is the honest choice, and it has a cost: FDA prints the same company several different ways.
The Index does not maintain a corporate-family alias map in this version, so it cannot and does not claim to count companies. The collapse test above is deliberately shallow — it drops legal-form tokens (Inc., LLC, Ltd. and the like, case-insensitively) and nothing else. It will not merge a subsidiary with its parent, a company with the name it traded under before an acquisition, or two spellings that differ by a real word. Anywhere the site says manufacturer, read it as the name FDA printed on that record.
Where a record itself carries acquisition text in the applicant field, that text is shown exactly as filed rather than being cleaned up, because editing it would mean asserting a corporate fact the record does not state.
Cadence & corrections
| What | Cadence | How it works |
|---|---|---|
| Clearance feed | Weekly | The 510(k) window is re-fetched and the front page rebuilt. New clearances appear at the top; nothing is back-edited silently. |
| Evidence counts | Monthly | PubMed and ClinicalTrials.gov counts move constantly. They are refetched monthly and the fetch date is printed next to them, because a citation count without a date is not a citation count. |
| Product codes and crosswalk | On change | Adding, removing or re-categorising a product code changes what the whole site counts, so it is done deliberately and noted here rather than drifting. |
| Query strings | Versioned | The current set is v1-2026-07-25. If a query is rewritten the version string changes and the previous string stays published. |
| Corrections | three business days | Write to damini@automationcoreinc.com. Acknowledged and either corrected or answered with the source record within three business days. Corrections are made on the page itself, and one that changes a published number is noted there rather than quietly swapped. |
That applies to manufacturers too. A manufacturer gets exactly the same correction route as anyone else, and no more: a factual error gets fixed, and a request to remove or soften an accurate figure sourced from a public record does not.
Independence
| Policy | What it means |
|---|---|
| Ranking inputs are not for sale | No placement fee, no sponsored slot, no priority listing, no pay-to-be-included. Every input to every ranking is a count computed from a public record by the published query. No amount of money moves a product up a list, because there is no field a payment could touch. |
| No manufacturer supplies data | Nothing here comes from a vendor feed, a press release, a spec sheet or a rep. If a manufacturer sends a correction, it is checked against the public record before anything changes. |
| Commercial relationships are disclosed inline | If the Index or its parent company ever has a commercial relationship with a company whose product appears here, the disclosure appears on the affected card itself, next to the product, not buried on a policy page. As of this build there are none. |
| Free, and it stays free | The catalogue, the counts and the sources are readable without an account, a paywall or an email address. |
| Who publishes this | The Dalphene Index is published by Automation Core, Inc., which also builds Dalphene, a practice-management platform for medical-aesthetic clinics. That is the relevant conflict to know about, so it is stated here and in the footer of every page. The platform sells to clinics, not to device manufacturers, and no device manufacturer pays for anything on this site. |
The long-term plan for this index is a usage signal drawn from real anonymised, aggregated platform telemetry. If and when that ships it will be labelled as exactly what it is — what a defined set of clinics actually used — with its denominator printed next to it. It will not be presented as a market share figure, and it will not be purchasable either.
Not published
| Source | Endpoint never called | Why |
|---|---|---|
| MAUDE device adverse events | https://api.fda.gov/device/event.json | Adverse-event counts are reporting artifacts, not risk rates. There is no denominator (units sold / procedures performed), reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them next to brand names would be actively misleading. The Dalphene Index does not fetch, store or display them. |
| FAERS drug adverse events | https://api.fda.gov/drug/event.json | Same reason as MAUDE. Not fetched, not stored, not displayed. |
Adverse-event counts (MAUDE and FAERS)
No adverse-event number appears anywhere on this site. Not per device, not per category, not as a chart, not as a rank.
The reason is arithmetic before it is anything else: an adverse-event report count has no denominator. Nobody publishes how many units of a device were sold or how many procedures were performed with it, so a raw report count cannot be turned into a rate. Reporting is voluntary for most reporters and duplicated across manufacturers, importers and facilities, so the count also measures how much attention and litigation a brand attracts. A report is not a finding of causation. FDA states plainly that its device-report data alone cannot be used to establish event rates, to judge whether an event rate is changing over time, or to compare event rates between devices — which is precisely what a reader would do with a number printed next to a brand name.
A popular device with a big installed base will always generate more reports than an obscure one. Publishing that next to brand names would look like a safety ranking and would be an artefact of market size. So the Index does not fetch these endpoints, does not store them, and does not display them. If you need them, they are public and they should be read with a clinician and with their limitations in front of you.
Vendor pricing
There is no price on this site: not a device price, not a consumable price, not a per-treatment price. There is no lawful public source for it. Capital-equipment pricing in aesthetics is quoted per buyer, moves with trade-ins, bundles, consumable commitments and territory, and the quotes themselves are usually under confidentiality terms. Anything published would be either a scraped rumour or a number a vendor wanted seen. Both fail the one rule this site has.
The same goes for treatment prices charged to patients: they are set per clinic, per market and per operator, and a national average would be a fabrication with an average sign in front of it.
The absence of adverse-event and price data on this site is a deliberate editorial decision, not a gap in the data. It does not mean a device has no reported events, and it does not mean pricing is unavailable from the vendor. It means neither number can be published here honestly.
Limitations
| Limitation | Detail |
|---|---|
| The index is a seed, not a census | 136 products are indexed. That is a curated starting set of widely used products, not every product on the US market, so no count here is a market total. |
| Broad-mixed rows are not individually vetted | 138 of 231 clearances in the window come from broad-mixed codes, and some of them plainly are not aesthetic — a general-surgery device sits in the raw feed under a shared code. They are kept and flagged rather than hand-deleted, because hand-deleting rows is how a neutral feed quietly becomes an edited one. Narrow is the default view. |
| Clearance counts are filing activity | One platform can carry a dozen clearances for applicators, indications and software revisions. Counting them tells you about regulatory effort, not about products, quality or sales. |
| Evidence counts are age-biased | A modality with a five-decade literature will out-count one that is eight years old, every time, regardless of which works better. That is why a 10-year window is fetched and published next to the all-time count. |
| Registration is not evidence | A ClinicalTrials.gov record means a study was registered. It does not mean the study finished, published, or found anything, and device studies are registered less consistently than drug studies. |
| Recruiting counts are a snapshot | They were true on the fetch date printed at the top of this page and are already drifting. |
| Nothing here is a clinical recommendation | It is a record of what public databases say. Which treatment is right for a person is a decision for that person and their clinician. |
| Scope | Unresolved gap |
|---|---|
| devices | Halo: no confident 510(k) match; regulatory fields null |
| devices | Emsculpt NEO: no confident 510(k) match; regulatory fields null |
| devices | HydraFacial: no confident 510(k) match; regulatory fields null |
Network integrity for this build: 179 requests returned data, 5 returned an empty result set, 0 failed. No count anywhere on this site is missing because an API was unreachable — where a value is absent, the source record does not contain it.
All product names and trademarks are the property of their respective owners; use here is nominative and does not imply affiliation, sponsorship, or endorsement.