FDA 510(k) Applications Submitted by Topcon Medical Systems, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K083316 11/10/2008 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM TOPCON MEDICAL SYSTEMS, INC.
K031831 06/13/2003 TOPCON MODEL BV-1000 AUTOMATED SUBJECTIVE REFRACTION SYSTEM TOPCON MEDICAL SYSTEMS, INC.
K182376 08/31/2018 Harmony Topcon Medical Systems, Inc.
K072971 10/22/2007 TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS TOPCON MEDICAL SYSTEMS, INC.
K110489 02/22/2011 SLIT LAMP SL-2G TOPCON MEDICAL SYSTEMS, INC.
K132438 08/05/2013 IMAGENET 5 PC SOFTWARE SYSTEM TOPCON MEDICAL SYSTEMS, INC.
K132667 08/27/2013 SYNERGY ODM TOPCON MEDICAL SYSTEMS, INC.
K123101 10/04/2012 TRC-50DX RETINAL CAMERA TOPCON MEDICAL SYSTEMS, INC.
K093313 10/22/2009 SYNERGY TOPCON MEDICAL SYSTEMS, INC.
K151952 07/15/2015 Synergy ODM TOPCON MEDICAL SYSTEMS, INC.
K123460 11/09/2012 TRC-NW300 NON-MYDRIATIC RETINAL CAMERA TOPCON MEDICAL SYSTEMS, INC.


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