FDA 510(k) Application Details - K243978

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K243978
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Shenzhen Sunsred Technology Co.,Ltd
201, No. 22, Shijing Road, Fumin Community, Fucheng Street
Longhua District
Shenzhen CN
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Contact Xiufeng Cai
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 12/23/2024
Decision Date 06/20/2025
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 K243978


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