FDA 510(k) Application Details - K202390

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K202390
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Shenzhen Kaiyan Medical Co Ltd
40A Fuxin Road, Fuyong Subdistrict, BaoAn District
Shenzhen 518101 CN
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Contact Alain Dijkstra
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 08/21/2020
Decision Date 07/14/2021
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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