FDA 510(k) Application Details - K220248

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

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510(K) Number K220248
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Mareal Tech Co., Ltd
301,Building 1,No.2,Xiashiwei Road,Huaide Community,
Fuyong Street, Baoan District
Shenzhen 518000 CN
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Contact Liu Libin
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 01/31/2022
Decision Date 07/01/2022
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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