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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 K191571
Device Name UV Radiation Treatment System
Applicant
Xuzhou Yongkang Electronic Science Technology Co., Ltd.
4f Bldg. C8, 40 Jingshan Rd., Economic And Technological
Development Zone
Xuzhou,  CN 221000
Applicant Contact Kai Li
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm.608,# 738,Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/14/2019
Decision Date 02/06/2020
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
Predetermined Change
Control Plan Authorized		 No
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