FDA 510(k) Application Details - K230362

Device Classification Name Light Based Over-The-Counter Hair Removal

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510(K) Number K230362
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Leaflife Technology Co., Ltd
4F, Bldg. C, JMD Industrial Park, No.39 Qingfeng Blvd.,
Baolong Industrial Area, Longgang Dist.,
Shenzhen 518116 CN
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Contact Cheng Qiang
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 02/10/2023
Decision Date 09/11/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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