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FDA 510(k) Application Details - K233679
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K233679
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
Shenzhen, Nanshan District 518000 CN
Other 510(k) Applications for this Company
Contact
Blue Yang
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
11/16/2023
Decision Date
01/05/2024
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K233679
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