FDA 510(k) Application Details - K222316

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

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510(K) Number K222316
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Goodwind Technology Development CO., LTD
4th&5Th Floor,2nd Part Of Building A1,
Yinlong Industrial Park, Gate 292, Longgang Section Of Sh
Shenzhen 518116 CN
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Contact Ziming Yang
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 08/02/2022
Decision Date 09/28/2022
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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