FDA 510(k) Application Details - K113479

Device Classification Name	Ophthalmic Femtosecond Laser   More FDA Info for this Device
510(K) Number	K113479
Device Name	Ophthalmic Femtosecond Laser
Applicant	OPTIMEDICA CORPORATION 3100 CORONADO DRIVE SANTA CLARA, CA 95054 US Other 510(k) Applications for this Company
Contact	ALAN MARQUARDT Other 510(k) Applications for this Contact
Regulation Number	886.4390   More FDA Info for this Regulation Number
Classification Product Code	OOE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/2011
Decision Date	12/21/2011
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