FDA 510(k) Application Details - K230549

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

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510(K) Number K230549
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Xiazhifeng Electronic Co., Ltd.
201, No. 39, Longfeng Road, Xinsheng Community, Longgang
Street, Longgang District
Shenzhen 518116 CN
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Contact James Li
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 02/28/2023
Decision Date 04/25/2023
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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