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FDA 510(k) Application Details - K230351
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Ava Hu
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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