308nm Excimer UV-light Skin Therapy System— 510(k) K202827

Name: FDA 510(k) clearance K202827
Creator: U.S. Food and Drug Administration
Published: 2020-12-15

Substantially Equivalent

Shenzhen Gsd Tech Co., Ltd.

FDA 510(k) clearance K202827 for 308nm Excimer UV-light Skin Therapy System, Substantially Equivalent on 2020-12-15. Applicant: Shenzhen Gsd Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Gsd Tech Co., Ltd.
Product code: Code FTC
Device class: Class 2
Regulation: 21 CFR 878.4630
Advisory panel: General, Plastic Surgery
Date received: 2020-09-24
Decision date: 2020-12-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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