FDA 510(k) Application Details - K192432

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

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510(K) Number K192432
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Bosidin Technology Co., Ltd.
Rm. 101 & 201, Bldg. 4, Haoer Jiashitai Technology Park
Fengtang Avenue
Shenzhen 518000 CN
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Contact Wang Jiaoyan
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 09/05/2019
Decision Date 11/08/2019
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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