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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 Bldg., #33 Left E. Ave., 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
Predetermined Change
Control Plan Authorized		 No
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