FDA 510(k) Application Details - K152087

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K152087
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	HOME SKINOVATIONS LTD. Tabor Building, Shaar Yokneam Yoqneam Iillit 2069200 IL Other 510(k) Applications for this Company
Contact	Ahava Stein 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	07/27/2015
Decision Date	07/29/2016
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