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FDA 510(k) Application Details - K240649
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K240649
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-Distri
Shenzhen 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
03/07/2024
Decision Date
06/21/2024
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 K240649
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