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FDA 510(k) Application Details - K232939
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K232939
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Borria Technology Co., Ltd
Shenyan Road No.2015 Room 501 Building No.6 Pengwan
Community, Haishan Sub-District Yantian
Shenzhen 518081 CN
Other 510(k) Applications for this Company
Contact
Tiantian 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
09/20/2023
Decision Date
12/15/2023
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
FDA Source Information for K232939
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