CO2 Laser Therapy Systems— 510(k) K162398

Name: FDA 510(k) clearance K162398
Creator: U.S. Food and Drug Administration
Published: 2017-07-06

Substantially Equivalent

Beijing Sincoheren Science and Technology Development Co.

FDA 510(k) clearance K162398 for CO2 Laser Therapy Systems, Substantially Equivalent on 2017-07-06. Applicant: Beijing Sincoheren Science and Technology Development Co.. Device class: 2.

Clearance details

Applicant: Beijing Sincoheren Science and Technology Development Co.
Product code: Product code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2016-08-26
Decision date: 2017-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

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