FDA 510(k) Application Details - K250581

Device Classification Name	More FDA Info for this Device
510(K) Number	K250581
Device Name	KALA Red Light Face Mask (KALA-01)
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	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/27/2025
Decision Date	05/30/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review