Accure Acne, Inc.
510(k) · clearedClass IIK242035
Cleared2022Studies66Trials5
Hollywood Spectra — FDA clearance record and published evidence
Lutronic Corporation · Lasers & Light
510(k) · clearedClass IIK213569
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 cleared2007
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →19
Methodology →19
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
- Lutronic Corporation
- Category
- Lasers & Light
- Latest decision
- FDA records
- 6
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresMatched 6 openFDA 510(k) record(s) whose device_name contains 'spectra' and whose applicant contains 'Lutronic'. Every K-number, product code and date below is copied verbatim from that API response; none is inferred. modality left null: Q-switched NANOSECOND, not picosecond. Records are the Lutronic Spectra family (applicant filter 'Lutronic' removes 75 unrelated 'Spectra' devices: breast pumps, apheresis, MRI, dental). Note K091320 covers 'SPECTRA SP II, SPECTRA DENTA II', a dental variant in the same Lutronic Spectra lineage -- it is counted in record_count and a reviewer may want it excluded. 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 |
|---|---|---|---|
| K213569 | 510(k) — cleared | Primary | Open → |
| K113588 | 510(k) — cleared | — | Open → |
| K103455 | 510(k) — cleared | — | Open → |
| K091320 | 510(k) — cleared | — | Open → |
| K080248 | 510(k) — cleared | — | Open → |
| K073436 | 510(k) — cleared | — | Open → |
| Code | FDA device name | 21 CFR |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 878.4810 |
Cleared indication: not transcribed here — read it on K213569 → 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
- HOLLYWOOD SPECTRA
- Manufacturer
- Cynosure Lutronic Technology Corporation
- Basic UDI-DI
- 88002918210118AHE
- UDI-DI
- 08800291820491
- Risk class
- Class IIb
- Status in EUDAMED
- On the market
Open the EUDAMED record → We matched 1 further EUDAMED record 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
No treatment area could be derived: neither the modality's condition query nor the FDA product codes contained a term on the keyword list.
Sources
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name%3A%22Spectra%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
- FDA public record for K213569https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K213569
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 →