DERMACLEAR UV-B PHOTOTHERAPY SYSTEM— 510(k) K011197

Substantially Equivalent

Lumenis

FDA 510(k) clearance K011197 for DERMACLEAR UV-B PHOTOTHERAPY SYSTEM, Substantially Equivalent on 2001-12-14. Applicant: Lumenis. Device class: 2.

Clearance details

Applicant: Lumenis
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2001-04-19
Decision date: 2001-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, CA, US

Download summary PDF View on FDA.gov ↗

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