FDA 510(k) Application Details - K221569

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

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510(K) Number K221569
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Fansizhe Science And Technology Co., Ltd
2nd and 3rd floors, No. 17, Xinfa 2nd Road, Xinqiao
Community, Xinqiao Street, Baoan District
Shenzhen 518125 CN
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Contact Endang Cheng
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 05/31/2022
Decision Date 06/30/2022
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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