FDA 510(k) Application Details - K111493

Device Classification Name	Photocoagulator And Accessories   More FDA Info for this Device
510(K) Number	K111493
Device Name	Photocoagulator And Accessories
Applicant	NIDEK CO., LTD. 755 N. MATHILDA AVENUE SUITE 100 SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	MICHAEL J BILLIG Other 510(k) Applications for this Contact
Regulation Number	886.4690   More FDA Info for this Regulation Number
Classification Product Code	HQB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2011
Decision Date	07/27/2011
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