Accure Acne, Inc.
510(k) · clearedClass IIK242035
Cleared2022Studies66Trials5
Omnilux — FDA clearance record and published evidence
Globalmed Technologies · Lasers & Light
510(k) · clearedClass IIK210948
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 cleared2003
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →23
Methodology →23
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 →
Shares treatment areas — not a recommendation. What this measuresPicked mechanically, by rule and nothing else: products in the same Index category that share the most derived treatment areas with this one, ties broken alphabetically. Treatment areas are themselves derived by a published keyword rule run over a real source string, not copied from the cleared or approved indication, so a shared area means two products' source strings happened to use the same word. It does not mean the two products do the same job, it is not a claim that they are interchangeable, and it is not a recommendation.
Methodology →
Overview
- Modality
- —
- Manufacturer
- Globalmed Technologies
- Category
- Lasers & Light
- Latest decision
- FDA records
- 8
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresMatched 8 openFDA 510(k) record(s) whose device_name contains 'omnilux'. Every K-number, product code and date below is copied verbatim from that API response; none is inferred. modality left null: LED photobiomodulation, same reason as Celluma. GlobalMed Technologies acquired Omnilux Medical in 2016, which is why applicant strings differ across 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 |
|---|---|---|---|
| K210948 | 510(k) — cleared | Primary | Open → |
| K081307 | 510(k) — cleared | — | Open → |
| K072459 | 510(k) — cleared | — | Open → |
| K050216 | 510(k) — cleared | — | Open → |
| K043329 | 510(k) — cleared | — | Open → |
| K043317 | 510(k) — cleared | — | Open → |
| K030426 | 510(k) — cleared | — | Open → |
| K030883 | 510(k) — cleared | — | Open → |
| Code | FDA device name | 21 CFR |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 878.4810 |
| ILY | — | — |
| OHS | Light Based Over The Counter Wrinkle Reduction | 878.4810 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 878.4810 |
Cleared indication: not transcribed here — read it on K210948 → 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 →
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 |
|---|---|---|
| Wrinkles & lines | wrinkle | FDA product code OHS — Light Based Over The Counter Wrinkle Reduction |
| Acne | acne | FDA product code OLP — Over-The-Counter Powered Light Based Laser For Acne |
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%22Omnilux%22&sort=decision_date%3Adesc&limit=100
- openFDA classification record for product code GEXhttps://api.fda.gov/device/classification.json?search=product_code:%22GEX%22&limit=1
- openFDA classification record for product code OHShttps://api.fda.gov/device/classification.json?search=product_code:%22OHS%22&limit=1
- openFDA classification record for product code OLPhttps://api.fda.gov/device/classification.json?search=product_code:%22OLP%22&limit=1
- FDA public record for K210948https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K210948
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 →