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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 K173813
Device Name IPL Hair Removal Device Joy Version
Applicant
Shen Zhen Cosbeauty Co., Ltd.
Unita-3f, Qiao De Industrial Park, Tian Liao,
Guangming District
Shenzhen,  CN
Applicant Contact Nicole Hu
Correspondent
Sgs-Cstc Standards Technical Services Co., Ltd.
198 Kezhu Rd., Scientech Park Guangzhou
Guangzhou,  CN
Correspondent Contact Iris Fung
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
ONF  
Date Received12/15/2017
Decision Date 09/07/2018
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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