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FDA 510(k) Application Details - K240282
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K240282
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Dongguan Boyuan Intelligent Technology Co.,Ltd.
Room 801, Building 3, No.3 Kuiqiao Road, Puxin Lake,
Tangxia Town
Dongguan 523719 CN
Other 510(k) Applications for this Company
Contact
Jinlong Li
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
02/01/2024
Decision Date
04/03/2024
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 K240282
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