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FDA 510(k) Application Details - K230090
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K230090
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Wuhan Lotuxs Technology Co., Ltd.
501/E2, Future City, No.999 high-tech avenue
Wuhan 430206, China(Free Trade Zone/Wuhan Area)
Wuhan 430075 CN
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Contact
Na Wu
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
01/12/2023
Decision Date
04/19/2023
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
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