FDA 510(k) Application Details - K241857

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K241857
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Dongguan Boyuan Intelligent Technology Co., Ltd.
Room 801, Building 3, No.3 Kuiqiao Road, Puxin Lake, Tangxia
Dongguan 523719 CN
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Contact Le Li
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 06/27/2024
Decision Date 10/11/2024
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 K241857


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