FDA 510(k) Application Details - K021696

Device Classification Name	Powered Laser Surgical Instrument   More FDA Info for this Device
510(K) Number	K021696
Device Name	Powered Laser Surgical Instrument
Applicant	OPHTHALMED LLC 1308 MORNINGSIDE PARK DR. ALPHARETTA, GA 30022 US Other 510(k) Applications for this Company
Contact	JAY MANSOUR 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	05/22/2002
Decision Date	08/20/2002
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