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FDA 510(k) Application Details - K241834
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K241834
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Yang Wo Electronic Co., Ltd
101# 3Bldg, The third industry, Shangshi jia Village,
Shijia Community, Matian Street, GuangMing District
Shenzhen 518106 CN
Other 510(k) Applications for this Company
Contact
Ken Wang
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
06/25/2024
Decision Date
09/23/2024
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 K241834
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