EDGE CO2 LASER SYSTEM— 510(k) K100590

Substantially Equivalent

Jm System Co., Ltd.

FDA 510(k) clearance K100590 for EDGE CO2 LASER SYSTEM, Substantially Equivalent on 2010-11-10. Applicant: Jm System Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jm System Co., Ltd.
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2010-03-02
Decision date: 2010-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Geumchen-Gu, Seoul,, KR

Download summary PDF View on FDA.gov ↗

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