FDA 510(k) Application Details - K230090

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

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510(K) Number K230090
Device Name Light Based Over-The-Counter Hair Removal
Applicant Wuhan Lotuxs Technology Co., Ltd.
501/E2, Future City, No.999 high-tech avenue
Wuhan 430206, China(Free Trade Zone/Wuhan Area)
Wuhan 430075 CN
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Contact Na Wu
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 01/12/2023
Decision Date 04/19/2023
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



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