FDA 510(k) Application Details - K241205

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

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510(K) Number K241205
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Ulike Smart Electronics Co., Ltd.
810, Bldg 1,Xunmei Science and Technology Plaza,No. 8 Keyuan
Rd., Science Park Community,Yuehai Sub-District, Nanshan Dis
Shenzhen 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 04/30/2024
Decision Date 09/09/2024
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 K241205


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