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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 K211922
Device Name IPL Home Use Hair Removal Device
Applicant
Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.
Rm. 501, Bldg. 4, Haoer Jiashitai Technology Park, Fengtang
Ave. # 164, Heping Community
Shenzhen,  CN 518100
Applicant Contact Luo Huajun
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received06/21/2021
Decision Date 09/20/2021
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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