FDA 510(k) Application Details - K233679

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

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510(K) Number K233679
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Ulike Smart Electronics Co.,Ltd
810, Building 1, Xunmei Science and Technology Plaza
No.8 Keyuan Road, Science Park Community,Yuehai Sub-District
Shenzhen, Nanshan District 518000 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 11/16/2023
Decision Date 01/05/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233679


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