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FDA 510(k) Application Details - K232846
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K232846
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Shenzhen MEIK Beauty Industry Co., Ltd
Bldg 202, Bldg A, Hejing Industrial Zone, High Tech Park
Zhancheng Community, Fuhai Street, Bbao'an District
Shenzhen 518100 CN
Other 510(k) Applications for this Company
Contact
Xuegang Zhang
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
09/14/2023
Decision Date
12/07/2023
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
FDA Source Information for K232846
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