Agnes Medical Co., Ltd. · RF & Microneedling
510(k) · clearedClass IIK250217
Cleared2017Studies354Trials37
Devices linked to skin laxity
22 products · matched by keyword rule, not the cleared indication
22 products
Endymed Medical, Ltd. · RF & Microneedling
510(k) · clearedClass IIK130501
Cleared2014Studies354Trials37
Invasix , Ltd. · RF & Microneedling
510(k) · clearedClass IIK102461
Cleared2011Studies354Trials37
Cynosure Lutronic Technology Corporation · RF & Microneedling
510(k) · clearedClass IIK253484EU
Cleared2018Studies354Trials37
Lutronic Corporation · RF & Microneedling
510(k) · clearedClass IIK121481
Cleared2013Studies354Trials37
Jeisys Medical, Inc. · RF & Microneedling
510(k) · clearedClass IIK183284
Cleared2016Studies354Trials37
InMode , Ltd. · RF & Microneedling
510(k) · clearedClass IIK240017EU
Cleared2019Studies354Trials37
Jeisys Medical, Inc. · RF & Microneedling
510(k) · clearedClass IIK231216EU
Cleared2020Studies354Trials37
Candela Corporation · RF & Microneedling
510(k) · clearedClass IIK240070
Cleared2016Studies354Trials37
Merz North America, Inc. · Injectables
PMA · approvedP050037
Approved2006Studies582Trials7
VIOL Co., Ltd. · RF & Microneedling
510(k) · clearedClass IIK180872
Cleared2018Studies354Trials37
Ilooda Co,., Ltd. · RF & Microneedling
510(k) · clearedClass IIK233374
Cleared2023Studies354Trials37
Ilooda Co,., Ltd. · RF & Microneedling
510(k) · clearedClass IIK182355
Cleared2017Studies354Trials37
Sofwave Medical, Ltd. · Body Contouring
510(k) · clearedClass IIK250146EU
Cleared2021Studies317Trials16
VIOL Co., Ltd. · RF & Microneedling
510(k) · clearedClass IIK213612EU
Cleared2020Studies354Trials37
Cynosure, LLC · RF & Microneedling
510(k) · clearedClass IIK223292EU
Cleared2017Studies432Trials9
Solta Medical · RF & Microneedling
510(k) · clearedClass IIK173759EU
Cleared2000Studies432Trials9
Ulthera, Inc. · Body Contouring
510(k) · clearedClass IIK260618
Cleared2009Studies317Trials16
Venus Concept USA, Inc. · RF & Microneedling
510(k) · clearedClass IIK201164
Cleared2015Studies354Trials37
ShenB Co., Ltd. · RF & Microneedling
510(k) · clearedClass IIK211562
Cleared2021Studies354Trials37
ShenB Co., Ltd. · RF & Microneedling
510(k) · clearedClass IIK193070EU
Cleared2016Studies354Trials37
Classys, Inc. · RF & Microneedling
510(k) · clearedClass IIK240248EU
Cleared2024Studies432Trials9
| Product | Manufacturer | Category | Pathway | Class | First decision | Studies | Trials |
|---|---|---|---|---|---|---|---|
| Agnes RF | Agnes Medical Co., Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Jan 5 2017 | 354 | 37 |
| EndyMed Intensif | Endymed Medical, Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Mar 13 2014 | 354 | 37 |
| Fractora | Invasix , Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Jun 2 2011 | 354 | 37 |
| Genius EU | Cynosure Lutronic Technology Corporation | RF & Microneedling | 510(k) — cleared | Class II | Dec 10 2018 | 354 | 37 |
| Infini | Lutronic Corporation | RF & Microneedling | 510(k) — cleared | Class II | Jun 25 2013 | 354 | 37 |
| INTRAcel | Jeisys Medical, Inc. | RF & Microneedling | 510(k) — cleared | Class II | Jul 21 2016 | 354 | 37 |
| Morpheus8 EU | InMode , Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Dec 27 2019 | 354 | 37 |
| Potenza EU | Jeisys Medical, Inc. | RF & Microneedling | 510(k) — cleared | Class II | Feb 20 2020 | 354 | 37 |
| Profound | Candela Corporation | RF & Microneedling | 510(k) — cleared | Class II | Sep 12 2016 | 354 | 37 |
| Radiesse | Merz North America, Inc. | Injectables | PMA — approved | — | Dec 22 2006 | 582 | 7 |
| Scarlet SRF | VIOL Co., Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Oct 11 2018 | 354 | 37 |
| Secret Pro | Ilooda Co,., Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Dec 14 2023 | 354 | 37 |
| Secret RF | Ilooda Co,., Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Jun 13 2017 | 354 | 37 |
| Sofwave EU | Sofwave Medical, Ltd. | Body Contouring | 510(k) — cleared | Class II | Nov 15 2021 | 317 | 16 |
| Sylfirm X EU | VIOL Co., Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Apr 22 2020 | 354 | 37 |
| TempSure EU | Cynosure, LLC | RF & Microneedling | 510(k) — cleared | Class II | Sep 22 2017 | 432 | 9 |
| Thermage EU | Solta Medical | RF & Microneedling | 510(k) — cleared | Class II | Jul 19 2000 | 432 | 9 |
| Ultherapy | Ulthera, Inc. | Body Contouring | 510(k) — cleared | Class II | Sep 11 2009 | 317 | 16 |
| Venus Viva | Venus Concept USA, Inc. | RF & Microneedling | 510(k) — cleared | Class II | May 12 2015 | 354 | 37 |
| VirtueRF | ShenB Co., Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Jan 22 2021 | 354 | 37 |
| Vivace EU | ShenB Co., Ltd. | RF & Microneedling | 510(k) — cleared | Class II | Jan 15 2016 | 354 | 37 |
| Volnewmer EU | Classys, Inc. | RF & Microneedling | 510(k) — cleared | Class II | Apr 29 2024 | 432 | 9 |
No product matches these filters.
Missing a device? Report it and it goes into the monthly review.
Curated seed list; study and trial counts are per modality, not per brand. What this measuresThis is a curated seed list of widely used medical-aesthetic products, each crosswalked to a real FDA record where one could be found with confidence. Being listed is not an endorsement, not a ranking and not a claim of market share. Being absent is not a judgement — it means the product is not in this seed list yet. Counts beside each filter are live counts of the products currently matching your other filters. Manufacturer is the applicant or sponsor field of the FDA record, printed exactly as FDA publishes it, so one company can appear under more than one string.
Methodology →
Sorted by most recent FDA decision — a filing date, not a quality signal. What each ordering measuresEvery ordering on this page is a proxy built from public records, never a quality judgement. Orders products by the most recent FDA decision date matched to the brand name, including later submissions and supplements. A recent date means the manufacturer filed again; it does not mean the product is newer, improved, more popular or better. Orders products by the number of PubMed records matching a fixed query for the product's MODALITY, never its brand name. It counts 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 between techniques of different ages. Orders products by the number of ClinicalTrials.gov studies matching a fixed intervention-plus-condition query for the product's MODALITY, never its brand. Registration is not completion, not publication and not a result. Alphabetical by product name. No ranking, quality judgement or ordering of merit is implied by the position of anything in this list. Orders products by the earliest FDA decision date matched to the brand name. For drugs approved under a BLA or NDA the original approval can long predate any cosmetic indication, so an early date is not a cosmetic-use date.
Methodology →
How each product matched (22)
| Product | Matched term | Source string |
|---|---|---|
| Agnes RF | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| EndyMed Intensif | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Fractora | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Genius | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Infini | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| INTRAcel | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Morpheus8 | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Potenza | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Profound | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Radiesse | skin laxity | ClinicalTrials.gov condition query for Calcium hydroxylapatite filler |
| Scarlet SRF | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Secret Pro | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Secret RF | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Sofwave | skin laxity | ClinicalTrials.gov condition query for Ultrasound lifting & tightening |
| Sylfirm X | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| TempSure | skin laxity | ClinicalTrials.gov condition query for Monopolar RF skin tightening |
| Thermage | skin laxity | ClinicalTrials.gov condition query for Monopolar RF skin tightening |
| Ultherapy | skin laxity | ClinicalTrials.gov condition query for Ultrasound lifting & tightening |
| Venus Viva | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| VirtueRF | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Vivace | skin laxity | ClinicalTrials.gov condition query for Radiofrequency microneedling |
| Volnewmer | skin laxity | ClinicalTrials.gov condition query for Monopolar RF skin tightening |
Derived by keyword rule from real source strings, not the cleared indication. What this measuresTreatment areas are DERIVED, not copied from an FDA field. A fixed keyword list is run over two real strings: the ClinicalTrials.gov condition query actually executed for this product's modality on the run date, and the device names of the FDA product codes attached to this product's records. The words "skin" and "cosmetic" are ignored because every query contains one of them. An area is not the cleared or approved indication — openFDA's 510(k) response does not carry the indications-for-use text, and this Index does not paraphrase it. Products whose source query names skin laxity.
Methodology →