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FDA 510(k) Application Details - K243017
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K243017
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Foshan Newface Electronic Technology Co., Ltd.
Floor 4--5, No.13, Hengsan Road, Shabu Industrial, ShaChong,
Lishui Town Nanhai District
Foshan 528244 CN
Other 510(k) Applications for this Company
Contact
Jiazhen Peng
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
OHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2024
Decision Date
05/06/2025
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 K243017
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