FDA 510(k) Application Details - K250938

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

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510(K) Number K250938
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Ulike Smart Electronics Co., Ltd.
810,Bldg 1,Xunmei Science and Tech Plaza, No.8 Keyuan Rd.
Science Park Community, Yuehai Sub-District, Nanshan Dist
Shenzhen CN
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Contact Blue Yang
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 03/28/2025
Decision Date 05/23/2025
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 K250938


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