Medical Device Manufacturer · US , Paramus , NJ

Topcon Corp. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2004

Recent clearances: TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA, SLIT LAMP SL-D701, TRC-NW8 NON-MYDRIATIC RETINAL CAMERA

View 9 510(k) Devices ↓ Official Website
9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Topcon Corp. Ophthalmic ✕

9 devices
1-9 of 9
Cleared Oct 23, 2014
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
K141325 · HKI
Ophthalmic · 156d
Cleared Aug 26, 2014
SLIT LAMP SL-D701
K133667 · HJO
Ophthalmic · 270d
Cleared May 10, 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289 · HKI
Ophthalmic · 94d
Cleared Feb 12, 2010
NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
K100207 · HKI
Ophthalmic · 18d
Cleared Sep 02, 2009
OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
K092470 · OBO
Ophthalmic · 21d
Cleared Jun 30, 2009
RETINA CAMERA TRC-NW7SF MARK II
K090115 · HKI
Ophthalmic · 160d
Cleared Sep 30, 2008
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR...
K082364 · NFJ
Ophthalmic · 43d
Cleared Jun 22, 2007
TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
K063388 · OBO
Ophthalmic · 226d
Cleared Nov 05, 2004
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
K041367 · HKI
Ophthalmic · 165d
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