FDA 510(k) Application Details - K111108

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K111108
Device Name	Laser, Ophthalmic
Applicant	TOPCON MEDICAL LASER SYSTEMS, INC 3130 CORONADO DRIVE SANTA CLARA, CA 95054 US Other 510(k) Applications for this Company
Contact	JOHN JOSSY Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	HQF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/20/2011
Decision Date	08/11/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review