FDA 510(k) Application Details - K250171

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

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510(K) Number K250171
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Yang Wo Electronic Co., Ltd.
101# 3Bldg, The third industry, Shangshi jia Village
Shijia Community, Matian Street, GuangMing District
Shenzhen 518106 CN
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Contact Ken Wang
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 01/21/2025
Decision Date 03/19/2025
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

FDA Source Information for K250171


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