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FDA 510(k) Application Details - K233887
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K233887
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen Ulike Smart Electronics Co.,Ltd
810, Building 1, Xunmei Science and Technology Plaza
No.8 Keyuan Road, Science Park Community,Yuehai Sub-District
Nanshan District, Shenzhen 518000 CN
Other 510(k) Applications for this Company
Contact
Blue Fang
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
12/08/2023
Decision Date
01/22/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K233887
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