FDA 510(k) Application Details - K112154

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K112154
Device Name	Laser, Ophthalmic
Applicant	SIE AG,SURGICAL INSTUMENT ENGINEERING 5401 S. COTTONWOOD CT. GREENWOOD VILLAGE, CO 80121 US Other 510(k) Applications for this Company
Contact	Kevin Walls 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	07/27/2011
Decision Date	03/16/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review