FDA 510(k) Application Details - K080591

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K080591
Device Name	Powered Laser Surgical Instrument
Applicant	PHAROS LIFE CORPORATION 11-380 JAMIESON PKWY CAMBRIDGE N3C 4N4 CA Other 510(k) Applications for this Company
Contact	PHIL CUSCUNA 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	03/03/2008
Decision Date	11/14/2008
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