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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 K213020
Device Name IPL hair removal machine
Applicant
Shenzhen Borria Technology Co., Ltd.
22a, Tianmian City Bldg., #4026 Shennan Middle Rd.,
Tianmian Community, Huafu St., Futian District
Shenzhen,  CN 518000
Applicant Contact Li Zhenqiang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Center, # 3101-90
Qianhai Rd., Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Rain Yip
Regulation Number878.4810
Classification Product Code
OHT  
Date Received09/20/2021
Decision Date 12/16/2021
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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