FDA 510(k) Application Details - K232939

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

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510(K) Number K232939
Device Name Light Based Over-The-Counter Hair Removal
Applicant Shenzhen Borria Technology Co., Ltd
Shenyan Road No.2015 Room 501 Building No.6 Pengwan
Community, Haishan Sub-District Yantian
Shenzhen 518081 CN
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Contact Tiantian Wang
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 09/20/2023
Decision Date 12/15/2023
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

FDA Source Information for K232939


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