FDA 510(k) Application Details - K240649

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

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510(K) Number K240649
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-Distri
Shenzhen 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 03/07/2024
Decision Date 06/21/2024
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 K240649


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