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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 K222710
Device Name IPL Cooling Hair Removal Device
Applicant
Shenzhen Siken 3D Technology Development Co., Ltd.
4th Building,No.33 Left East Avenue,Songgang,
Bao'an District
Shenzhen,  CN 518105
Applicant Contact Jingquan Liu
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received09/08/2022
Decision Date 12/01/2022
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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