FDA 510(k) Application Details - K221466

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

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510(K) Number K221466
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Century Dongyuan Technology Co Ltd.
Floor 2, Building B1, Gonghe Fourth Industrial Zone,
Shajing Street Bao'an District
Shenzhen 518104 CN
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Contact He Wang
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 05/19/2022
Decision Date 08/12/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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