Accure Acne, Inc.
510(k) · clearedClass IIK242035
Cleared2022Studies66Trials5
Lasers & Light — 45 devices on the FDA record
46 of 136 products · 45 510(k) · 1 No matched record
510(k) clearances per year
2015–2026 · 2026 partial
| Lasers & Light | Total | |
|---|---|---|
| 2015 | 68 | 68 |
| 2016 | 77 | 77 |
| 2017 | 93 | 93 |
| 2018 | 90 | 90 |
| 2019 | 67 | 67 |
| 2020 | 70 | 70 |
| 2021 | 89 | 89 |
| 2022 | 123 | 123 |
| 2023 | 114 | 114 |
| 2024 | 141 | 141 |
| 2025 | 168 | 168 |
| 2026 | 63 | 63 |
510(k) clearance decisions per year in this category's device codes — filing activity, not sales or clinical benefit. What this measuresCount of FDA 510(k) clearance decisions per year whose product code is in each Dalphene category group. Not approvals, not efficacy, not safety, not sales — filing activity only. Category groups include broad-mixed codes (GEX in lasers-light, GEI in rf-microneedling, NGX in body-contouring), so these yearly totals carry non-aesthetic devices too; the per-code split is not fetched per year. 2026 is a partial year through the run date. Unlike the monthly series, these are count queries — there is no narrow-only variant here because a per-breadth split would double the request count. Charts using this series must carry the broad-mixed caveat on the chart. 2026 covers 01-01 through the run date (2026-07-26) only.
Methodology →
46 products
Lumenis, Ltd.
510(k) · clearedClass IIK212703EU
Cleared2008Studies1,485Trials229
Aerolase Medical Lasers, LLC
510(k) · clearedClass IIK120235
Cleared2012Studies—Trials—
Alma Lasers, Inc.
510(k) · clearedClass IIK251230EU
Cleared2021Studies1,485Trials229
Cynosure, Inc.
510(k) · clearedClass IIK034030
Cleared2000Studies744Trials30
Cutera, Inc.
510(k) · clearedClass IIK251149EU
Cleared2022Studies66Trials5
Sciton, Inc
510(k) · clearedClass IIK032460
Cleared2003Studies1,028Trials43
Sun Pharmaceutical Industries, Inc.
510(k) · clearedClass IIK241358
Cleared2003Studies—Trials—
Biophotas, Inc.
510(k) · clearedClass IIK232977EU
Cleared2014Studies—Trials—
Lutronic Corporation
510(k) · clearedClass IIK183566EU
Cleared2013Studies744Trials30
Solta Medical, Inc.
510(k) · clearedClass IIK223647EU
Cleared2011Studies1,157Trials128
Syneron-Candela Corp
510(k) · clearedClass IIK181523
Cleared2015Studies1,485Trials229
Cynosure, Inc.
510(k) · clearedClass IIK050779EU
Cleared2005Studies1,530Trials72
Inmode MD , Ltd.
510(k) · clearedClass IIK180719
Cleared2015Studies744Trials30
Quanta System Spa
510(k) · clearedClass IIK240983EU
Cleared2016Studies323Trials27
Lutronic Corporation
510(k) · clearedClass IIK244060
Cleared2008Studies1,485Trials229
Cynosure, LLC
510(k) · clearedClass IIK240396
Cleared2020Studies744Trials30
Cutera, Inc.
510(k) · clearedClass IIK182997EU
Cleared2016Studies323Trials27
Candela Corporation
510(k) · clearedClass IIK212492EU
Cleared2016Studies1,157Trials128
Solta Medical
510(k) · clearedClass IIK242142EU
Cleared2005Studies1,157Trials128
Candela Corp.
510(k) · clearedClass IIK140732EU
Cleared1997Studies744Trials30
Candela Corporation
510(k) · clearedClass IIK201111EU
Cleared2011Studies744Trials30
Maker —
Unverified mapping
Decision—Studies1,485Trials229
Alma Lasers, Inc.
510(k) · clearedClass IIK243044
Cleared2008Studies1,028Trials43
Lutronic Corporation
510(k) · clearedClass IIK213569EU
Cleared2007Studies—Trials—
Cynosure, Inc.
510(k) · clearedClass IIK142376EU
Cleared2011Studies1,028Trials43
Lutronic Global
510(k) · clearedClass IIK192331EU
Cleared2017Studies1,157Trials128
Lumenis, Ltd.
510(k) · clearedClass IIK170179EU
Cleared1998Studies744Trials30
Led Intellectual Properties, LLC
510(k) · clearedClass IIK212771EU
Cleared2010Studies—Trials—
El.En S.P.A.
510(k) · clearedClass IIK241459EU
Cleared2017Studies744Trials30
Candela Corporation
510(k) · clearedClass IIK212492EU
Cleared2015Studies1,028Trials43
Globalmed Technologies
510(k) · clearedClass IIK210948
Cleared2003Studies—Trials—
Wontech Co., Ltd.
510(k) · clearedClass IIK181272
Cleared2017Studies323Trials27
Lutronic Corporation
510(k) · clearedClass IIK173700
Cleared2018Studies323Trials27
Cynosure, LLC
510(k) · clearedClass IIK261570EU
Cleared2012Studies323Trials27
Candela Corporation
510(k) · clearedClass IIK220853EU
Cleared2015Studies323Trials27
Cynosure, Inc.
510(k) · clearedClass IIK133254EU
Cleared2006Studies—Trials—
El.En S.P.A.
510(k) · clearedClass IIK240537EU
Cleared2003Studies1,485Trials229
Alma Lasers, Inc.
510(k) · clearedClass IIK230371EU
Cleared2009Studies744Trials30
Fotona D.O.O.
510(k) · clearedClass IIK213267
Cleared2011Studies1,485Trials229
Bios S.R.L.
510(k) · clearedClass IIK243445EU
Cleared2024Studies744Trials30
Lumenis Be, Ltd.
510(k) · clearedClass IIK250809EU
Cleared2015Studies1,028Trials43
Jeisys Medical Incorporated
510(k) · clearedClass IIK251464
Cleared2025Studies—Trials—
Lumenis Be, Ltd.
510(k) · clearedClass IIK233301EU
Cleared1991Studies1,485Trials229
Candela Corporation
510(k) · clearedClass IIK230990EU
Cleared2002Studies1,530Trials72
Palomar Medical Technologies, Inc.
510(k) · clearedClass IIK120622EU
Cleared2012Studies744Trials30
| Product | Manufacturer | Category | Pathway | Class | First decision | Studies | Trials |
|---|---|---|---|---|---|---|---|
| Accure | Accure Acne, Inc. | Lasers & Light | 510(k) — cleared | Class II | Nov 17 2022 | 66 | 5 |
| AcuPulse EU | Lumenis, Ltd. | Lasers & Light | 510(k) — cleared | Class II | Dec 18 2008 | 1,485 | 229 |
| Aerolase | Aerolase Medical Lasers, LLC | Lasers & Light | 510(k) — cleared | Class II | Sep 17 2012 | — | — |
| Alma Hybrid EU | Alma Lasers, Inc. | Lasers & Light | 510(k) — cleared | Class II | Jul 2 2021 | 1,485 | 229 |
| Apogee Elite | Cynosure, Inc. | Lasers & Light | 510(k) — cleared | Class II | Jun 29 2000 | 744 | 30 |
| AviClear EU | Cutera, Inc. | Lasers & Light | 510(k) — cleared | Class II | Mar 24 2022 | 66 | 5 |
| BBL | Sciton, Inc | Lasers & Light | 510(k) — cleared | Class II | Nov 13 2003 | 1,028 | 43 |
| BLU-U | Sun Pharmaceutical Industries, Inc. | Lasers & Light | 510(k) — cleared | Class II | Sep 9 2003 | — | — |
| Celluma EU | Biophotas, Inc. | Lasers & Light | 510(k) — cleared | Class II | Jan 15 2014 | — | — |
| Clarity II EU | Lutronic Corporation | Lasers & Light | 510(k) — cleared | Class II | Nov 22 2013 | 744 | 30 |
| Clear + Brilliant EU | Solta Medical, Inc. | Lasers & Light | 510(k) — cleared | Class II | May 3 2011 | 1,157 | 128 |
| CO2RE | Syneron-Candela Corp | Lasers & Light | 510(k) — cleared | Class II | Sep 15 2015 | 1,485 | 229 |
| Cynergy EU | Cynosure, Inc. | Lasers & Light | 510(k) — cleared | Class II | Jan 12 2005 | 1,530 | 72 |
| Diolaze | Inmode MD , Ltd. | Lasers & Light | 510(k) — cleared | Class II | Jan 13 2015 | 744 | 30 |
| Discovery Pico EU | Quanta System Spa | Lasers & Light | 510(k) — cleared | Class II | Dec 5 2016 | 323 | 27 |
| eCO2 | Lutronic Corporation | Lasers & Light | 510(k) — cleared | Class II | Jul 7 2008 | 1,485 | 229 |
| Elite iQ | Cynosure, LLC | Lasers & Light | 510(k) — cleared | Class II | Mar 9 2020 | 744 | 30 |
| enlighten EU | Cutera, Inc. | Lasers & Light | 510(k) — cleared | Class II | Oct 28 2016 | 323 | 27 |
| Frax EU | Candela Corporation | Lasers & Light | 510(k) — cleared | Class II | Sep 16 2016 | 1,157 | 128 |
| Fraxel EU | Solta Medical | Lasers & Light | 510(k) — cleared | Class II | Jul 5 2005 | 1,157 | 128 |
| GentleLase EU | Candela Corp. | Lasers & Light | 510(k) — cleared | Class II | Dec 4 1997 | 744 | 30 |
| GentleMax Pro EU | Candela Corporation | Lasers & Light | 510(k) — cleared | Class II | Oct 5 2011 | 744 | 30 |
| Halo | — | Lasers & Light | Not verified | — | — | 1,485 | 229 |
| Harmony XL | Alma Lasers, Inc. | Lasers & Light | 510(k) — cleared | Class II | May 23 2008 | 1,028 | 43 |
| Hollywood Spectra EU | Lutronic Corporation | Lasers & Light | 510(k) — cleared | Class II | Dec 28 2007 | — | — |
| Icon EU | Cynosure, Inc. | Lasers & Light | 510(k) — cleared | Class II | Jun 22 2011 | 1,028 | 43 |
| LaseMD EU | Lutronic Global | Lasers & Light | 510(k) — cleared | Class II | Jun 23 2017 | 1,157 | 128 |
| LightSheer EU | Lumenis, Ltd. | Lasers & Light | 510(k) — cleared | Class II | May 4 1998 | 744 | 30 |
| LightStim EU | Led Intellectual Properties, LLC | Lasers & Light | 510(k) — cleared | Class II | Jul 1 2010 | — | — |
| Motus EU | El.En S.P.A. | Lasers & Light | 510(k) — cleared | Class II | Jun 19 2017 | 744 | 30 |
| Nordlys EU | Candela Corporation | Lasers & Light | 510(k) — cleared | Class II | Jul 7 2015 | 1,028 | 43 |
| Omnilux | Globalmed Technologies | Lasers & Light | 510(k) — cleared | Class II | Jun 18 2003 | — | — |
| PicoCare | Wontech Co., Ltd. | Lasers & Light | 510(k) — cleared | Class II | Jun 12 2017 | 323 | 27 |
| PicoPlus | Lutronic Corporation | Lasers & Light | 510(k) — cleared | Class II | Jun 19 2018 | 323 | 27 |
| PicoSure EU | Cynosure, LLC | Lasers & Light | 510(k) — cleared | Class II | Nov 27 2012 | 323 | 27 |
| PicoWay EU | Candela Corporation | Lasers & Light | 510(k) — cleared | Class II | Apr 16 2015 | 323 | 27 |
| RevLite EU | Cynosure, Inc. | Lasers & Light | 510(k) — cleared | Class II | Dec 1 2006 | — | — |
| SmartXide EU | El.En S.P.A. | Lasers & Light | 510(k) — cleared | Class II | May 9 2003 | 1,485 | 229 |
| Soprano EU | Alma Lasers, Inc. | Lasers & Light | 510(k) — cleared | Class II | Apr 14 2009 | 744 | 30 |
| SP Dynamis | Fotona D.O.O. | Lasers & Light | 510(k) — cleared | Class II | Jul 1 2011 | 1,485 | 229 |
| Splendor X EU | Bios S.R.L. | Lasers & Light | 510(k) — cleared | Class II | Jun 14 2024 | 744 | 30 |
| Stellar M22 EU | Lumenis Be, Ltd. | Lasers & Light | 510(k) — cleared | Class II | Jan 21 2015 | 1,028 | 43 |
| TRI-BEAM | Jeisys Medical Incorporated | Lasers & Light | 510(k) — cleared | Class II | Oct 3 2025 | — | — |
| UltraPulse EU | Lumenis Be, Ltd. | Lasers & Light | 510(k) — cleared | Class II | Aug 13 1991 | 1,485 | 229 |
| Vbeam EU | Candela Corporation | Lasers & Light | 510(k) — cleared | Class II | Feb 11 2002 | 1,530 | 72 |
| Vectus EU | Palomar Medical Technologies, Inc. | Lasers & Light | 510(k) — cleared | Class II | May 23 2012 | 744 | 30 |
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 →
Comparisons in this category
BBL vs IPL
Clear + Brilliant vs fractional laser
Fraxel vs fractional laser
Halo vs fractional ablative laser
PicoCare vs picosecond laser
PicoSure vs picosecond laser
PicoWay vs picosecond laser
Soprano vs laser hair removal
Stellar M22 vs IPL
Clear + Brilliant vs Fraxel
Fraxel vs Halo
PicoSure vs PicoWay
Which pairs exist is editorial — observed search demand, not a judgement about any product. What this measuresWhich brands get a comparison page is the ONE editorial decision on this site, and this is it stated plainly. Every brand with a comparison page was observed in a live Google or Bing autocomplete list on 2026-07-26 — that is the entire membership rule, and the seed query each brand was seen under is published in the source of this page. It is a record of what people type, not a judgement about the products: a brand with a page is not better, more popular or more recommended than a brand without one, and a brand without one is missing only because nobody has yet seen it in an autocomplete list. Nothing else on this site is chosen this way; every figure on the page below is copied mechanically from a public record.
Methodology →