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FDA 510(k) Application Details - K230107
Device Classification Name
Light Based Over-The-Counter Hair Removal
More FDA Info for this Device
510(K) Number
K230107
Device Name
Light Based Over-The-Counter Hair Removal
Applicant
Kam Yuen Plastic Products Ltd.
No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town
ZhongShan CN
Other 510(k) Applications for this Company
Contact
Anna Dan
Other 510(k) Applications for this Contact
Regulation Number
878.4810
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Classification Product Code
OHT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/13/2023
Decision Date
04/05/2023
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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