FDA 510(k) Application Details - K251017

Device Classification Name	Laser, Comb, Hair   More FDA Info for this Device
510(K) Number	K251017
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 Baoan 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	04/02/2025
Decision Date	06/17/2025
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