IPL THERAPY SYSTEM— 510(k) K123435

Name: FDA 510(k) clearance K123435
Creator: U.S. Food and Drug Administration
Published: 2013-02-11

Substantially Equivalent

Beijing Sincoheren S&T Development Co, Ltd.

FDA 510(k) clearance K123435 for IPL THERAPY SYSTEM, Substantially Equivalent on 2013-02-11. Applicant: Beijing Sincoheren S&T Development Co, Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Sincoheren S&T Development Co, Ltd.
Product code: Code ONF
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2012-11-07
Decision date: 2013-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, Guangdong, CN

Download summary PDF View on FDA.gov ↗

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