FDA 510(k) Application Details - K173660

Device Classification Name	Ophthalmic Femtosecond Laser   More FDA Info for this Device
510(K) Number	K173660
Device Name	Ophthalmic Femtosecond Laser
Applicant	Alcon Laboratories, Inc. 20511 Lake Forest Dr Lake Forest, CA 92630 US Other 510(k) Applications for this Company
Contact	James Arganda 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	11/29/2017
Decision Date	03/27/2018
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