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FDA 510(k) Application Details - K232124
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K232124
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Wochuan Electronic Co., Ltd
6th Floor Building No.357 3rd Area A Huayuan Xingye 1 Road
Fenghuang Community Fuyong Street Street
Shenzhen 518103 CN
Other 510(k) Applications for this Company
Contact
Rebecca Jiang
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
07/17/2023
Decision Date
09/14/2023
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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