Alma Lasers, Inc.
510(k) · clearedClass IIK101147EU
Cleared2007Studies255Trials0
Body Contouring — 21 devices on the FDA record
22 of 136 products · 21 510(k) · 1 No matched record
510(k) clearances per year
2015–2026 · 2026 partial
| Body Contouring | Total | |
|---|---|---|
| 2015 | 17 | 17 |
| 2016 | 14 | 14 |
| 2017 | 17 | 17 |
| 2018 | 9 | 9 |
| 2019 | 21 | 21 |
| 2020 | 17 | 17 |
| 2021 | 18 | 18 |
| 2022 | 12 | 12 |
| 2023 | 25 | 25 |
| 2024 | 17 | 17 |
| 2025 | 21 | 21 |
| 2026 | 7 | 7 |
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 →
22 products
Revelle Aesthetics, Inc.
510(k) · clearedClass IIK232153
Cleared2022Studies50Trials4
Ulthera, Inc.
510(k) · clearedClass IIK192185
Cleared2015Studies50Trials4
Cynosure, Inc.
510(k) · clearedClass IIK123407EU
Cleared2012Studies50Trials4
Zeltiq Aesthetics, Inc.
510(k) · clearedClass IIK193566
Cleared2012Studies245Trials20
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
510(k) · clearedClass IIK233732EU
Cleared2021Studies245Trials20
Zimmer Medizinsysteme GmbH
510(k) · clearedClass IIK253408
Cleared2019Studies61Trials4
Erchonia Corporation
510(k) · clearedClass IIK192544
Cleared2020Studies112Trials0
Maker —
Unverified mapping
Decision—Studies61Trials4
BTL Industries, Inc.
510(k) · clearedClass IIK163176
Cleared2009Studies255Trials0
Bios S.R.L.
510(k) · clearedClass IIK230755EU
Cleared2020Studies255Trials0
Cynosure
510(k) · clearedClass IIK182741
Cleared2015Studies112Trials0
Sofwave Medical, Ltd.
510(k) · clearedClass IIK250146EU
Cleared2021Studies317Trials16
Cutera, Inc.
510(k) · clearedClass IIK180709EU
Cleared2012Studies255Trials0
Johari Digital Healthcare Limited
510(k) · clearedClass IIK212866
Cleared2022Studies—Trials—
Cutera, Inc.
510(k) · clearedClass IIK223110EU
Cleared2022Studies255Trials0
Ulthera, Inc.
510(k) · clearedClass IIK260618
Cleared2009Studies317Trials16
Syneron Medical, Ltd.
510(k) · clearedClass IIK170370
Cleared2014Studies—Trials—
Syneron Medical, Ltd.
510(k) · clearedClass IIK122579
Cleared2007Studies255Trials0
Venus Concept USA, Inc.
510(k) · clearedClass IIK220592
Cleared2019Studies112Trials0
Venus Concept USA, Inc.
510(k) · clearedClass IIK191528
Cleared2015Studies255Trials0
Erchonia Corporation
510(k) · clearedClass IIK243811
Cleared2012Studies112Trials0
| Product | Manufacturer | Category | Pathway | Class | First decision | Studies | Trials |
|---|---|---|---|---|---|---|---|
| Accent EU | Alma Lasers, Inc. | Body Contouring | 510(k) — cleared | Class II | Apr 23 2007 | 255 | 0 |
| Aveli | Revelle Aesthetics, Inc. | Body Contouring | 510(k) — cleared | Class II | Aug 5 2022 | 50 | 4 |
| Cellfina | Ulthera, Inc. | Body Contouring | 510(k) — cleared | Class II | Jul 29 2015 | 50 | 4 |
| Cellulaze EU | Cynosure, Inc. | Body Contouring | 510(k) — cleared | Class II | Jan 26 2012 | 50 | 4 |
| CoolSculpting | Zeltiq Aesthetics, Inc. | Body Contouring | 510(k) — cleared | Class II | May 2 2012 | 245 | 20 |
| CoolSculpting Elite EU | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | Body Contouring | 510(k) — cleared | Class II | Nov 5 2021 | 245 | 20 |
| CoolTone | Zimmer Medizinsysteme GmbH | Body Contouring | 510(k) — cleared | Class II | Nov 15 2019 | 61 | 4 |
| Emerald Laser | Erchonia Corporation | Body Contouring | 510(k) — cleared | Class II | Jan 13 2020 | 112 | 0 |
| Emsculpt NEO | — | Body Contouring | Not verified | — | — | 61 | 4 |
| Exilis | BTL Industries, Inc. | Body Contouring | 510(k) — cleared | Class II | Nov 25 2009 | 255 | 0 |
| NuEra Tight EU | Bios S.R.L. | Body Contouring | 510(k) — cleared | Class II | Aug 11 2020 | 255 | 0 |
| SculpSure | Cynosure | Body Contouring | 510(k) — cleared | Class II | May 15 2015 | 112 | 0 |
| Sofwave EU | Sofwave Medical, Ltd. | Body Contouring | 510(k) — cleared | Class II | Nov 15 2021 | 317 | 16 |
| truSculpt EU | Cutera, Inc. | Body Contouring | 510(k) — cleared | Class II | Nov 2 2012 | 255 | 0 |
| truSculpt flex | Johari Digital Healthcare Limited | Body Contouring | 510(k) — cleared | Class II | Dec 3 2022 | — | — |
| truSculpt iD EU | Cutera, Inc. | Body Contouring | 510(k) — cleared | Class II | Jul 13 2022 | 255 | 0 |
| Ultherapy | Ulthera, Inc. | Body Contouring | 510(k) — cleared | Class II | Sep 11 2009 | 317 | 16 |
| UltraShape | Syneron Medical, Ltd. | Body Contouring | 510(k) — cleared | Class II | Oct 6 2014 | — | — |
| VelaShape | Syneron Medical, Ltd. | Body Contouring | 510(k) — cleared | Class II | Aug 22 2007 | 255 | 0 |
| Venus Bliss | Venus Concept USA, Inc. | Body Contouring | 510(k) — cleared | Class II | Jun 25 2019 | 112 | 0 |
| Venus Legacy | Venus Concept USA, Inc. | Body Contouring | 510(k) — cleared | Class II | Aug 4 2015 | 255 | 0 |
| Zerona | Erchonia Corporation | Body Contouring | 510(k) — cleared | Class II | May 14 2012 | 112 | 0 |
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
Accent vs RF body contouring
CoolSculpting vs cryolipolysis
CoolSculpting Elite vs cryolipolysis
CoolTone vs muscle stimulation
Emerald Laser vs laser lipolysis
Emsculpt NEO vs muscle stimulation
Exilis vs RF body contouring
NuEra Tight vs RF body contouring
SculpSure vs laser lipolysis
Sofwave vs ultrasound skin tightening
truSculpt vs RF body contouring
Ultherapy vs ultrasound skin tightening
VelaShape vs RF body contouring
Venus Legacy vs RF body contouring
CoolSculpting vs CoolSculpting Elite
CoolSculpting vs CoolTone
CoolSculpting vs Emsculpt NEO
CoolSculpting vs SculpSure
CoolTone vs Emsculpt NEO
Emsculpt NEO vs SculpSure
Emsculpt NEO vs truSculpt
Morpheus8 vs Sofwave
Morpheus8 vs Ultherapy
Sofwave vs Thermage
Sofwave vs Ultherapy
Thermage vs Ultherapy
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 →