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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name light, ultraviolet, dermatological
510(k) Number K202827
Device Name 308nm Excimer UV-light Skin Therapy System
Applicant
Shenzhen GSD Tech Co., Ltd.
Building A, JUNSD Hi-Tech Park, West of Bao’An RD.
Watch & Clock Base, Guangming District
Shenzhen,  CN 518106
Applicant Contact Zoe Yao
Correspondent
Shenzhen GSD Tech Co., Ltd.
Building A, JUNSD Hi-Tech Park, West of Bao’An RD.
Watch & Clock Base, Guangming District
Shenzhen,  CN 518106
Correspondent Contact Zoe Yao
Regulation Number878.4630
Classification Product Code
FTC  
Date Received09/24/2020
Decision Date 12/15/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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