Accure Acne, Inc.
510(k) · clearedClass IIK242035
Cleared2022Studies66Trials5
Celluma — FDA clearance record and published evidence
Biophotas, Inc. · Lasers & Light
510(k) · clearedClass IIK232977
PathwayPathwayA 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product.
Methodology →510(k) · cleared
Methodology →510(k) · cleared
ClassII
First cleared2014
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →12
Methodology →12
StudiesStudiesPubMed records for a fixed query about 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 between modalities of different ages. It says nothing about this brand specifically.
Methodology →—
Methodology →—
TrialsTrialsClinicalTrials.gov studies for a fixed query about the MODALITY, not the brand. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies.
Methodology →—
Methodology →—
A 510(k) device is cleared, not approved — a different route, not a lesser one. What this measuresA 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product. 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 between modalities of different ages. It says nothing about this brand specifically.
Methodology →
Overview
- Modality
- —
- Manufacturer
- Biophotas, Inc.
- Category
- Lasers & Light
- Latest decision
- FDA records
- 3
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresMatched 3 openFDA 510(k) record(s) whose device_name contains 'celluma' and whose applicant contains 'Biophotas'. Every K-number, product code and date below is copied verbatim from that API response; none is inferred. modality left null: LED photobiomodulation is not one of the 25 modalities this Index tracks, so no literature or trial counts are attached to this product. K232977 (Celluma CONTOUR) carries product code OLI, a BODY-CONTOURING code, so this brand family spans two of the five categories; the card is filed under Lasers & Light on the strength of the other two records. One or more of the matched records carries FDA product code ILY, which this index's product-code curation explicitly REJECTS as non-aesthetic (ILY: Infrared heating lamps for temporary pain relief. Used by some aesthetic manufacturers but the code itself is a heating lamp, not an aesthetic indication.). The records are kept because the record's own device_name names this brand, but a rejected code contributes no device class and no derived treatment area anywhere on the site. A mapping is the weakest link on this page: if it is wrong, every number above it is about the wrong product. It is stated in full so it can be checked.
Methodology →
Regulatory
| Identifier | Type | Role | FDA record |
|---|---|---|---|
| K232977 | 510(k) — cleared | Primary | Open → |
| K211038 | 510(k) — cleared | — | Open → |
| K131113 | 510(k) — cleared | — | Open → |
| Code | FDA device name | 21 CFR |
|---|---|---|
| ILY | — | — |
| OAP | Laser, Comb, Hair | 890.5500 |
| OLI | Fat Reducing Low Level Laser | 878.5400 |
Cleared indication: not transcribed here — read it on K232977 → Cleared indicationopenFDA's release of this database does not return the indications-for-use text, and this Index will not paraphrase a regulatory statement it has not transcribed. A 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product.
Methodology →
EUDAMEDAlso registered in the EU
- Listed as
- Celluma
- Manufacturer
- BioPhotas, Inc.
- Basic UDI-DI
- B-00850523007082
- UDI-DI
- 00850523007082
- Risk class
- Class IIa
- Status in EUDAMED
- On the market
Open the EUDAMED record → We matched 27 further EUDAMED records for this brand; this is the one shown.
Registered in EUDAMED, the EU device database. A registration, not an approval. What this measuresListed in EUDAMED, the EU medical device database, as of Jul 26 2026. EUDAMED registration became mandatory in May 2026 with a transition period, so devices not listed here may still be CE marked — we show only records we could match. A EUDAMED entry is a registration, not an FDA-style clearance or approval, and says nothing about safety, efficacy or quality. The name and manufacturer shown are spelled exactly as EUDAMED spells them.
Methodology →
Evidence
No modality is assigned to this product, so no literature or trial counts are shown.
Treatment areas
What matched, and where
| Area | Matched term | Source string |
|---|---|---|
| Hair growth | comb, hair | FDA product code OAP — Laser, Comb, Hair |
| Fat & body contouring | fat reduc | FDA product code OLI — Fat Reducing Low Level Laser |
Derived by keyword rule, not the cleared or approved 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.
Methodology →
Sources
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name%3A%22Celluma%22&sort=decision_date%3Adesc&limit=100
- openFDA classification record for product code OAPhttps://api.fda.gov/device/classification.json?search=product_code:%22OAP%22&limit=1
- openFDA classification record for product code OLIhttps://api.fda.gov/device/classification.json?search=product_code:%22OLI%22&limit=1
- FDA public record for K232977https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K232977
No adverse-event data is published anywhere on this site. What this measuresNo adverse-event data appears anywhere on this site. MAUDE and FAERS were never queried: those counts have no denominator, reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them beside a brand name would mislead.
Methodology →