308nm Excimer System— 510(k) K192642

Name: FDA 510(k) clearance K192642
Creator: U.S. Food and Drug Administration
Published: 2020-05-13

Substantially Equivalent

Chongqing Peninsula Medical Technology Co., Ltd.

FDA 510(k) clearance K192642 for 308nm Excimer System, Substantially Equivalent on 2020-05-13. Applicant: Chongqing Peninsula Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Chongqing Peninsula Medical Technology Co., Ltd.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2019-09-24
Decision date: 2020-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chongqing, CN

Download summary PDF View on FDA.gov ↗

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