Identifiers
- 510(k) Number
- K883952 FDA 510(k)
- FDA Product Code
- FTC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4630 FDA 510(k)
- Regulation Number
- 878.4630 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The U. V. Sunlamp 95UF-11 is an ultraviolet dermatological light device. It is designed to emit ultraviolet radiation for clinical applications.
This device is manufactured by Light Sources, Inc. and has received FDA 510(k) clearance. It is classified under regulation number 878.4630.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: FDA Browser - Cleared 510 (K) - U. V. SUNLAMP 95UF-11 (K883952), U.V. SUNLAMP 95UF-11 (K870167) — FDA 510 (k) | Innolitics, Product code FTC — SUNLAMP · DeviceClearance, U.V. SUNLAMP 95UF-II 510 (k) K901324 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K883952 | Class II | Active |
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Manufacturer
- Manufacturer
- Light Sources, Inc.
Sources (1)
- FDA 510(k) K883952 24 fields · synced Sep 21, 2026