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FDA 510(k) Application Details - K242385
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K242385
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
Shenzhen Borria Technology Co., Ltd
501, Floor 5, Building 6, Industrial Zone, No.2015, Shenyan
Road, Pengwan Community, Haishan Street, Yantian District
Shenzhen CN
Other 510(k) Applications for this Company
Contact
Chardy Wang
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
08/12/2024
Decision Date
04/07/2025
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 K242385
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