FDA 510(k) Application Details - K230097

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

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510(K) Number K230097
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen BSX Technology Electronics Co., Ltd.
Rm101&2/F~4/F, Building No.13, Ailian Industrial Park
Wulian Community, LongGang District
Shenzhen 518116 CN
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Contact Hong Li
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 01/13/2023
Decision Date 04/06/2023
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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