SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY— 510(k) K061589

Name: FDA 510(k) clearance K061589
Creator: U.S. Food and Drug Administration
Published: 2006-08-04

Substantially Equivalent

Solarc Systems, Inc.

FDA 510(k) clearance K061589 for SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY, Substantially Equivalent on 2006-08-04. 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: 2006-06-08
Decision date: 2006-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Barrie, Ontario, CA

Download summary PDF View on FDA.gov ↗

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