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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, # 39 Qingfeng Blvd.
Bao Long Industrial Area, Long Gang Dist.
Shenzhen,  CN 518116
Applicant Contact Cheng Qiang
Correspondent
Shenzhen Leaflife Technology Co., Ltd.
4f, Bldg. C, Jmd Industrial Park, # 39 Qingfeng Blvd.
Bao Long Industrial Area, Long Gang 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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