Identifiers
- 510(k) Number
- K021762 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 Bclear is a computerized targeted photoclearing system designed for dermatological light therapy. It functions by delivering ultraviolet light through a fiber-optic cable to treat conditions such as eczema.
This device is classified as a Class 2 ultraviolet dermatological light system under regulation number 878.4630. It has received FDA 510(k) clearance via the traditional pathway.
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: K021762 FDA 510(k) - BCLEAR | Lumenis, Inc., Bclear 510 (k) FDA Premarket Notification K020591 LUMENIS, PDF 510(k) Summary of Safety and Effectiveness, FDA approves Lumenis’s BClear system for eczema treatment
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K021762 | Class II | Active |
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Manufacturer
- Manufacturer
- Lumenis Inc.
- FDA Applicant
- Lumenis, Inc.
Sources (1)
- FDA 510(k) K021762 24 fields · synced Sep 23, 2026