FDA 510(k) Application Details - K243017

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

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510(K) Number K243017
Device Name Light Based Over-The-Counter Hair Removal
Applicant Foshan Newface Electronic Technology Co., Ltd.
Floor 4--5, No.13, Hengsan Road, Shabu Industrial, ShaChong,
Lishui Town Nanhai District
Foshan 528244 CN
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Contact Jiazhen Peng
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 09/27/2024
Decision Date 05/06/2025
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 K243017


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