FDA 510(k) Application Details - K250761

Device Classification Name	Light Based Over The Counter Wrinkle Reduction   More FDA Info for this Device
510(K) Number	K250761
Device Name	Light Based Over The Counter Wrinkle Reduction
Applicant	SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD Building #3, and Building#5 40th of Fuxin street, Huaide Community, Fuyong Town,áBaoan District ShenZhen 518003 CN Other 510(k) Applications for this Company
Contact	Alain Dijkstra Other 510(k) Applications for this Contact
Regulation Number	878.4810   More FDA Info for this Regulation Number
Classification Product Code	OHS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2025
Decision Date	07/11/2025
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