FDA 510(k) Application Details - K123542

Device Classification Name	Laser, Ophthalmic   More FDA Info for this Device
510(K) Number	K123542
Device Name	Laser, Ophthalmic
Applicant	TOPCON MEDICAL LASER SYSTEMS, INC 2800 PLEASANT HILL RD., SUITE 175 PLEASANT HILL, CA 94553 US Other 510(k) Applications for this Company
Contact	PAMELA M BUCKMAN 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	11/19/2012
Decision Date	05/15/2013
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