FDA 510(k) Application Details - K251984

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

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510(K) Number K251984
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 Pk Cmty Yuehai Sub-Dist. Nanshan Dist
Shenzhen 518000 CN
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Contact Yang Blue
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 06/27/2025
Decision Date 07/24/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K251984


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