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FDA 510(k) Application Details - K231321
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K231321
Device Name
Laser, Comb, Hair
Applicant
Shenzhen Kaiyan Medical Equipment Co., Ltd
Building#3 and Building#5, 40th of Fuxin Street
Huaide Community, Fuyong Town,áBaoan District
Shenzhen 518103 CN
Other 510(k) Applications for this Company
Contact
Alain Dijkstra
Other 510(k) Applications for this Contact
Regulation Number
890.5500
More FDA Info for this Regulation Number
Classification Product Code
OAP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/08/2023
Decision Date
07/31/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
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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