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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 K192432
Device Name IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130
Applicant
Shenzhen Bosidin Technology Co., Ltd.
Rm. 101 & 201, Bldg. 4, Haoer Jiashitai Technology Park
Fengtang Avenue
Shenzhen,  CN 518000
Applicant Contact Wang Jiaoyan
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm. 3005, Area B, Bldg. 1, Southward Ruifeng Business Center
Guimiao Road
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received09/05/2019
Decision Date 11/08/2019
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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