FDA 510(k) Application Details - K240093

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

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510(K) Number K240093
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Shuge Medical Beauty Devices Co., Ltd.
6th Floor, Building B, Jingang Science Park
Qiaotou Community, Baoan District
Shenzhen 518103 CN
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Contact Shengbiao Lin
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 01/12/2024
Decision Date 04/24/2024
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

FDA Source Information for K240093


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