308nm Excimer System— 510(k) K200971

Name: FDA 510(k) clearance K200971
Creator: U.S. Food and Drug Administration
Published: 2020-12-15

Substantially Equivalent

Xuzhou Kernel Medical Equipment Co., Ltd.

FDA 510(k) clearance K200971 for 308nm Excimer System, Substantially Equivalent on 2020-12-15. Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2020-04-13
Decision date: 2020-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xuzhou, CN

Download summary PDF View on FDA.gov ↗

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