FDA 510(k) Application Details - K222710

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

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510(K) Number K222710
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Siken 3D Technology Development Co., Ltd.
4th Building,No.33 Left East Avenue,Songgang,
Bao'an District
Shenzhen 518105 CN
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Contact Jingquan Liu
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 09/08/2022
Decision Date 12/01/2022
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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