FDA 510(k) Application Details - K083848

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K083848
Device Name	Powered Laser Surgical Instrument
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	878.4810   More FDA Info for this Regulation Number
Classification Product Code	GEX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/24/2008
Decision Date	04/14/2009
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