FDA 510(k) Application Details - K251173

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

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510(K) Number K251173
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Fansizhe Science and Technology Co., Ltd.
2nd, 3rd and 4th floors, No.11, Henggangxia Industrial Zone
Xiangshan Community, Xinqiao Street, BaoÆan District
Shenzhen 518125 CN
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Contact Endang Cheng
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 04/16/2025
Decision Date 07/14/2025
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 K251173


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