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FDA 510(k) Application Details - K223928
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K223928
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Fansizhe Science And Technology Co., Ltd
2nd, 3rd And 4th Floors, No.11, Henggangxia Industrial Zone
Xiangshan Community, Xinqiao Street
Shenzhen 518125 CN
Other 510(k) Applications for this Company
Contact
Endang Cheng
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
12/30/2022
Decision Date
03/28/2023
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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