SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY— 510(k) K103204

Name: FDA 510(k) clearance K103204
Creator: U.S. Food and Drug Administration
Published: 2011-04-27

Substantially Equivalent

Solarc Systems, Inc.

FDA 510(k) clearance K103204 for SOLARC / SOLRX E-SERIES ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY, Substantially Equivalent on 2011-04-27. Applicant: Solarc Systems, Inc.. Device class: 2.

Clearance details

Applicant: Solarc Systems, Inc.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2010-11-01
Decision date: 2011-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minesing,Ontario, CA

Download summary PDF View on FDA.gov ↗

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