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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 K230362
Device Name Planar LED mate
Applicant
Shenzhen Leaflife Technology Co., Ltd
4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd.,
Baolong Industrial Area, Longgang Dist.,
Shenzhen,  CN 518116
Applicant Contact Cheng Qiang
Correspondent
Shenzhen Leaflife Technology Co., Ltd
4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd.,
Baolong Industrial Area, Longgang Dist.,
Shenzhen,  CN 518116
Correspondent Contact Cheng Qiang
Regulation Number878.4810
Classification Product Code
OHT  
Subsequent Product Code
GEX  
Date Received02/10/2023
Decision Date 09/11/2023
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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