VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100— 510(k) K061295

Name: FDA 510(k) clearance K061295
Creator: U.S. Food and Drug Administration
Published: 2006-05-25

Substantially Equivalent

Theralight, Inc.

FDA 510(k) clearance K061295 for VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100, Substantially Equivalent on 2006-05-25. Applicant: Theralight, Inc.. Device class: 2.

Clearance details

Applicant: Theralight, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2006-05-09
Decision date: 2006-05-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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