Agnes Medical Co., Ltd.
510(k) · clearedClass IIK250217
Cleared2017Studies354Trials37
RF & Microneedling — 24 devices on the FDA record
24 of 136 products · 24 510(k)
510(k) clearances per year
2015–2026 · 2026 partial
| RF & Microneedling | Total | |
|---|---|---|
| 2015 | 55 | 55 |
| 2016 | 72 | 72 |
| 2017 | 59 | 59 |
| 2018 | 52 | 52 |
| 2019 | 58 | 58 |
| 2020 | 69 | 69 |
| 2021 | 58 | 58 |
| 2022 | 66 | 66 |
| 2023 | 79 | 79 |
| 2024 | 71 | 71 |
| 2025 | 66 | 66 |
| 2026 | 40 | 40 |
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 →
24 products
Cytrellis Biosystems, Inc.
510(k) · clearedClass IIK252752
Cleared2025Studies619Trials135
Endymed Medical, Ltd.
510(k) · clearedClass IIK130501
Cleared2014Studies354Trials37
Invasix , Ltd.
510(k) · clearedClass IIK102461
Cleared2011Studies354Trials37
Cynosure Lutronic Technology Corporation
510(k) · clearedClass IIK253484EU
Cleared2018Studies354Trials37
Lutronic Corporation
510(k) · clearedClass IIK121481
Cleared2013Studies354Trials37
Jeisys Medical, Inc.
510(k) · clearedClass IIK183284
Cleared2016Studies354Trials37
Eclipse Medcorp, LLC
510(k) · clearedClass IIK212558
Cleared2021Studies619Trials135
InMode , Ltd.
510(k) · clearedClass IIK240017EU
Cleared2019Studies354Trials37
Jeisys Medical, Inc.
510(k) · clearedClass IIK231216EU
Cleared2020Studies354Trials37
Candela Corporation
510(k) · clearedClass IIK240070
Cleared2016Studies354Trials37
Refine USA, LLC
510(k) · clearedClass IIK192138
Cleared2020Studies619Trials135
VIOL Co., Ltd.
510(k) · clearedClass IIK180872
Cleared2018Studies354Trials37
Ilooda Co,., Ltd.
510(k) · clearedClass IIK233374
Cleared2023Studies354Trials37
Ilooda Co,., Ltd.
510(k) · clearedClass IIK182355
Cleared2017Studies354Trials37
Crown Aesthetics
510(k) · clearedClass IIK241400EU
Cleared2018Studies619Trials135
Esthetic Medical, Inc.
510(k) · clearedClass IIK253002
Cleared2020Studies619Trials135
VIOL Co., Ltd.
510(k) · clearedClass IIK213612EU
Cleared2020Studies354Trials37
Cynosure, LLC
510(k) · clearedClass IIK223292EU
Cleared2017Studies432Trials9
Solta Medical
510(k) · clearedClass IIK173759EU
Cleared2000Studies432Trials9
Venus Concept USA, Inc.
510(k) · clearedClass IIK201164
Cleared2015Studies354Trials37
ShenB Co., Ltd.
510(k) · clearedClass IIK211562
Cleared2021Studies354Trials37
ShenB Co., Ltd.
510(k) · clearedClass IIK193070EU
Cleared2016Studies354Trials37
Classys, Inc.
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 |
| ellacor | Cytrellis Biosystems, Inc. | RF & Microneedling | 510(k) — cleared | Class II | Oct 30 2025 | 619 | 135 |
| 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 |
| MicroPen EVO | Eclipse Medcorp, LLC | RF & Microneedling | 510(k) — cleared | Class II | May 25 2021 | 619 | 135 |
| 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 |
| Rejuvapen NXT | Refine USA, LLC | RF & Microneedling | 510(k) — cleared | Class II | Apr 9 2020 | 619 | 135 |
| 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 |
| SkinPen EU | Crown Aesthetics | RF & Microneedling | 510(k) — cleared | Class II | Mar 1 2018 | 619 | 135 |
| SkinStylus | Esthetic Medical, Inc. | RF & Microneedling | 510(k) — cleared | Class II | Apr 10 2020 | 619 | 135 |
| 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 |
| 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 →
Comparisons in this category
Agnes RF vs microneedling
Morpheus8 vs microneedling
Potenza vs microneedling
Scarlet SRF vs microneedling
SkinPen vs microneedling
Sylfirm X vs microneedling
TempSure vs RF skin tightening
Thermage vs RF skin tightening
Vivace vs microneedling
Volnewmer vs RF skin tightening
Morpheus8 vs Potenza
Morpheus8 vs Sculptra
Morpheus8 vs SkinPen
Morpheus8 vs Sofwave
Morpheus8 vs Thermage
Morpheus8 vs Ultherapy
Morpheus8 vs Vivace
Potenza vs SkinPen
Potenza vs Thermage
Potenza vs Vivace
SkinPen vs Vivace
Sofwave vs Thermage
Sylfirm X vs Vivace
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 →