FDA 510(k) Application Details - K161198

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K161198
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	USA LASER BIOTECH INC. 9210 FOREST HILL AVENUE SUITE B-3 RICHMOND, VA 23235 US Other 510(k) Applications for this Company
Contact	NELSON MARQUINA Other 510(k) Applications for this Contact
Regulation Number	890.5500   More FDA Info for this Regulation Number
Classification Product Code	ILY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/2016
Decision Date	07/26/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PM - Physical Medicine
Review Advisory Committee	PM - Physical Medicine
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review