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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over-The-Counter Hair Removal
510(k) Number K203510
Device Name IPL Hair removal
Applicant
Shenzhen Weikai Technology Co.,Ltd
Fl402, Bldg. A, #466 Jinbi Rd., Biling Community,
Biling St., Pingshan District
Shenzhen,  CN 518118
Applicant Contact Jing Li
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Center, # 3101-90
Qianhai Rd., Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received11/30/2020
Decision Date 02/26/2021
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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