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FDA 510(k) Application Details - K250880
Device Classification Name
Light Based Over The Counter Wrinkle Reduction
More FDA Info for this Device
510(K) Number
K250880
Device Name
Light Based Over The Counter Wrinkle Reduction
Applicant
Foshan Guangyu Weilai Medical Equipment Co., Ltd.
201, Block A, Zhongfa Zhaochuang Science and Technology Park
River Village, Lishui Town, Nanhai District
Foshan 528226 CN
Other 510(k) Applications for this Company
Contact
Guang Zhou
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
03/24/2025
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 K250880
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