Accure Acne, Inc. · Lasers & Light
510(k) · clearedClass IIK242035
Cleared2022Studies66Trials5
Devices linked to acne
11 products · matched by keyword rule, not the cleared indication
11 products
GALDERMA LABS LP · Skin & Topicals
NDA · approvedNDA211527
Approved2019Studies4,253Trials343
Cutera, Inc. · Lasers & Light
510(k) · clearedClass IIK251149EU
Cleared2022Studies66Trials5
GALDERMA LABS LP · Skin & Topicals
NDA · approvedNDA020380
Approved1996Studies4,253Trials343
Maker — · Skin & Topicals
Unverified mapping
Decision—Studies166Trials9
Led Intellectual Properties, LLC · Lasers & Light
510(k) · clearedClass IIK212771EU
Cleared2010Studies—Trials—
Globalmed Technologies · Lasers & Light
510(k) · clearedClass IIK210948
Cleared2003Studies—Trials—
VALEANT PHARMS NORTH · Skin & Topicals
NDA · approvedNDA021108
Approved2000Studies4,253Trials343
BAUSCH · Skin & Topicals
NDA · approvedNDA017340
Approved1973Studies4,253Trials343
ALMIRALL · Skin & Topicals
NDA · approvedNDA020600
Approved1997Studies4,253Trials343
SUN PHARM · Skin & Topicals
NDA · approvedNDA213433
Approved2020Studies90Trials21
| 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 |
| Aklief | GALDERMA LABS LP | Skin & Topicals | NDA — approved | — | Oct 4 2019 | 4,253 | 343 |
| AviClear EU | Cutera, Inc. | Lasers & Light | 510(k) — cleared | Class II | Mar 24 2022 | 66 | 5 |
| Differin | GALDERMA LABS LP | Skin & Topicals | NDA — approved | — | May 31 1996 | 4,253 | 343 |
| HydraFacial | — | Skin & Topicals | Not verified | — | — | 166 | 9 |
| LightStim EU | Led Intellectual Properties, LLC | Lasers & Light | 510(k) — cleared | Class II | Jul 1 2010 | — | — |
| Omnilux | Globalmed Technologies | Lasers & Light | 510(k) — cleared | Class II | Jun 18 2003 | — | — |
| Renova | VALEANT PHARMS NORTH | Skin & Topicals | NDA — approved | — | Aug 31 2000 | 4,253 | 343 |
| Retin-A | BAUSCH | Skin & Topicals | NDA — approved | — | Jan 26 1973 | 4,253 | 343 |
| Tazorac | ALMIRALL | Skin & Topicals | NDA — approved | — | Jun 13 1997 | 4,253 | 343 |
| Winlevi | SUN PHARM | Skin & Topicals | NDA — approved | — | Aug 26 2020 | 90 | 21 |
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 (11)
| Product | Matched term | Source string |
|---|---|---|
| Accure | acne | ClinicalTrials.gov condition query for Sebaceous-gland laser for acne |
| Aklief | acne | ClinicalTrials.gov condition query for Topical retinoid |
| AviClear | acne | ClinicalTrials.gov condition query for Sebaceous-gland laser for acne |
| Differin | acne | ClinicalTrials.gov condition query for Topical retinoid |
| HydraFacial | acne | ClinicalTrials.gov condition query for Hydradermabrasion |
| LightStim | acne | FDA product code OLP — Over-The-Counter Powered Light Based Laser For Acne |
| Omnilux | acne | FDA product code OLP — Over-The-Counter Powered Light Based Laser For Acne |
| Renova | acne | ClinicalTrials.gov condition query for Topical retinoid |
| Retin-A | acne | ClinicalTrials.gov condition query for Topical retinoid |
| Tazorac | acne | ClinicalTrials.gov condition query for Topical retinoid |
| Winlevi | acne | ClinicalTrials.gov condition query for Topical clascoterone |
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 or FDA product code names acne. The phrase "acne scars" is removed before this rule runs, so scarring counts as scarring and not as active acne.
Methodology →