FDA 510(k) Application Details - K080318

Device Classification Name	Lamp, Infrared, Therapeutic Heating   More FDA Info for this Device
510(K) Number	K080318
Device Name	Lamp, Infrared, Therapeutic Heating
Applicant	ALMA LASERS LTD. HALAMISH ST. POB 3021 INDUSTRIAL PARK CAESAREA 38900 IL Other 510(k) Applications for this Company
Contact	TATIANA EPSTEIN 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	02/06/2008
Decision Date	03/07/2008
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