FDA 510(k) Application Details - K230351

Device Classification Name Light Based Over The Counter Wrinkle Reduction

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510(K) Number K230351
Device Name Light Based Over The Counter Wrinkle Reduction
Applicant Shenzhen SUNGPO HI-TECH Electronic Co., Ltd
806 Chuangke Building, No.72-6 Huanguan South Road
Xintian Community, Guanhu Street, Longhu
Shenzhen 518000 CN
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Contact Ava Hu
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Regulation Number 878.4810

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Classification Product Code OHS
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Date Received 02/09/2023
Decision Date 05/05/2023
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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