FDA 510(k) Application Details - K150323

Device Classification Name	Ophthalmic Femtosecond Laser   More FDA Info for this Device
510(K) Number	K150323
Device Name	Ophthalmic Femtosecond Laser
Applicant	SIE AG,Surgical Instrument Engineering Allmendstrasse 11 Port CH2562 CH Other 510(k) Applications for this Company
Contact	Frank Ziemer 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	02/09/2015
Decision Date	10/23/2015
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