Every aesthetic device, on the public record
FDA clearances and what each was cleared to treat, a decade of published research, who paid for the trials, and side-by-side comparisons — for 130 lasers, injectables and body systems. Free, no sponsored listings.
Counts of records in this index, not of the US market. What this measuresCounts of records in this index, not of the US market. 125 of the 136 products are crosswalked to a real FDA record and 11 could not be, so their regulatory fields are blank on purpose. Clearances are 510(k) decisions in the 365-day window ending 25 Jul 2026. Manufacturer names are distinct applicant strings as FDA printed them, not companies. The trend line under the clearance count is decisions per full month of the same window across all tracked codes; the two partial edge months are excluded so they cannot read as a dip.
Methodology →
Clearances per month
narrow aesthetic codes · Aug 2025 – Jun 2026
| Lasers & Light | Body Contouring | Skin & Topicals | RF & Microneedling | Total | |
|---|---|---|---|---|---|
| Aug | 6 | 0 | 0 | 2 | 8 |
| Sep | 6 | 0 | 0 | 1 | 7 |
| Oct | 13 | 0 | 0 | 3 | 16 |
| Nov | 6 | 0 | 0 | 0 | 6 |
| Dec | 11 | 3 | 0 | 0 | 14 |
| Jan | 4 | 0 | 0 | 1 | 5 |
| Feb | 3 | 1 | 0 | 1 | 5 |
| Mar | 7 | 0 | 0 | 2 | 9 |
| Apr | 2 | 1 | 0 | 1 | 4 |
| May | 4 | 2 | 0 | 1 | 7 |
| Jun | 9 | 0 | 0 | 0 | 9 |
510(k) decisions per month in unambiguously aesthetic codes — filing tempo, not adoption. What this measuresCount of FDA 510(k) clearance DECISIONS per month whose product code is on the Dalphene aesthetic allowlist. A clearance is not an approval, not efficacy, not safety, not sales; manufacturers file multiple 510(k)s per platform, so this tracks filing activity. Zeros are real: the window's clearance list is complete, so an empty month is an empty month. The first month (2025-07) and last month (2026-07) cover only part of a calendar month because the window is a rolling 365 days ending 2026-07-25. The two partial edge months are excluded from this chart so they cannot read as a dip; legend values are each category's total over the 11 full months shown. Injectables never appear here because neuromodulators and fillers reach market via BLA/PMA, not 510(k).
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Cleared recently
| Device | Applicant | Decided | Pathway | FDA record |
|---|---|---|---|---|
| Capenergy C Equipments RF C200 and C400 Drakarian | Capenergy Medical S.L. | 10 Jul 2026 | 510(k) · cleared | K253480 |
| Chromix | Termosalud S.L. | 1 Jul 2026 | 510(k) · cleared | K261473 |
| LED Light Therapy Masks (LED Face Mask Pro FAC08NA… | Guangdong Newdermo Biotech Co., Ltd. | 29 Jun 2026 | 510(k) · cleared | K261052 |
| Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4… | Ziree Co., Ltd. | 26 Jun 2026 | 510(k) · cleared | K261253 |
| LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K… | Guangdong Newdermo Biotech Co., Ltd. | 18 Jun 2026 | 510(k) · cleared | K260946 |
| Laser Hair Growth Device (F21151, F21152, F21153… | Zdeer Technology (Henan) Co., Ltd. | 16 Jun 2026 | 510(k) · cleared | K260899 |
| LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 16 Jun 2026 | 510(k) · cleared | K254025 |
| Laser Hair Growth System (Laser Cap 128, Laser Helmet… | Hubei Yjt Technology Co.,Ltd | 16 Jun 2026 | 510(k) · cleared | K253231 |
| Intense Pulsed Light Therapy Device | Sanhe LEFIS Electronics Co., Ltd. | 12 Jun 2026 | 510(k) · cleared | K261204 |
| Alma TED+ System | Alma Lasers, Inc. | 5 Jun 2026 | 510(k) · cleared | K251684 |
A 510(k) clearance means FDA found the device substantially equivalent to one already on sale. What this measuresCount 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.
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Tile trends: 510(k) clearances per year, 2015–2025; injectables reach market via BLA/PMA, not 510(k). 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. No injectables group exists: neuromodulators (BLA) and fillers (PMA) are not 510(k) records. Absence is structural, not a gap. Tile trend lines cover full years only (2015–2025); the partial current year is excluded, never extrapolated.
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Most studied
- 1Topical retinoidAklief, Differin, Renova4,253+4%
- 2Exosome / extracellular-vesicle preparationASCE+2,396—
- 3Botulinum toxin (cosmetic)Botox Cosmetic, Daxxify, Dysport2,201+25%
- 4Pulsed dye laserCynergy, Vbeam1,530+13%
- 5Ablative / hybrid fractional laserAcuPulse, Alma Hybrid, CO2RE1,485+43%
Counts PubMed records per technique, not per brand — publication volume, not effectiveness. What this measuresNumber 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. Bars are proportional to the all-time count within this top 5; delta chips compare the two latest full years (2025 vs 2024) from the same fixed queries, so young techniques swing harder on small bases.
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Featured
Radiesse
Merz North America, Inc. · InjectablesPMA · approvedCalcium hydroxylapatite…Belotero Balance
Merz North America, Inc. · InjectablesPMA · approvedHyaluronic acid fillerThermage
Solta Medical · RF & Microneedling510(k) · clearedClass IIMonopolar RF skin tighteningFraxel
Solta Medical · Lasers & Light510(k) · clearedClass IINon-ablative fractional…CoolSculpting
Zeltiq Aesthetics, Inc. · Body Contouring510(k) · clearedClass IICryolipolysisRetin-A
BAUSCH · Skin & TopicalsNDA · approvedTopical retinoidPicked by a stated rule: most FDA records on file in each category. Filing volume, not quality. What this measuresPicked by a stated rule: most FDA records on file in each category. An FDA record count includes supplements, added applicators, added indications and software changes, so it measures regulatory paperwork — not effectiveness, not safety, not sales, not how many clinics use it. Study and trial counts are per technique, not per brand.
Methodology →