ClearanceBrief
Company ยท JP

Topcon Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2026. Name variants (Inc, Corp, punctuation) are merged.

23510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
OBOTomography, Optical Coherence8
HKICamera, Ophthalmic, Ac-Powered7
HJOBiomicroscope, Slit-Lamp, Ac-Powered3
NFJSystem, Image Management, Ophthalmic3
HKXTonometer, Ac-Powered1
NQEMicroscope, Specular1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Sep 18, 2026K262637SLIT LAMP SL-D4 (Type: LED)
Topcon Corporation, JP
HJO
Nov 7, 2025K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
Topcon Corporation, JP
HKX
Jul 17, 2024K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System
Topcon Corporation, JP
OBO
Apr 10, 2024K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
Topcon Corporation, JP
OBO
Mar 1, 2024K232828IMAGEnet6 Ophthalmic Data System
Topcon Corporation, JP
NFJ
Oct 30, 2023K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Topcon Corporation, JP
OBO
Aug 29, 2022K221111Non-Mydriatic Retinal Camera NW500
Topcon Corporation, JP
HKI
Jan 19, 2018K173119DRI OCT Triton
Topcon Corporation, JP
OBO
Nov 1, 2017K171370IMAGEnet 6 Ophthalmic Data System
Topcon Corporation, JP
NFJ
Mar 3, 2017K1701643D OCT-1 Maestro
Topcon Corporation, JP
OBO
Dec 9, 2016K161972Slit Lamp SL-D301
Topcon Corporation, JP
HJO
Jul 28, 2016K1615093D OCT-1 Maestro
Topcon Corporation, JP
OBO
May 29, 2015K142417SP-1PSpecular Microscope
Topcon Corporation, JP
NQE
Oct 23, 2014K141325TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
Topcon Corp.
HKI
Sep 17, 2014K141481TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
Topcon Corporation
HKI
Aug 26, 2014K133667SLIT LAMP SL-D701
Topcon Corp.
HJO
May 10, 2013K130289TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
Topcon Corp.
HKI
Feb 12, 2010K100207NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F
Topcon Corp., JP
HKI
Sep 2, 2009K092470OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000
Topcon Corp., JP
OBO
Jun 30, 2009K090115RETINA CAMERA TRC-NW7SF MARK II
Topcon Corp., JP
HKI
Sep 30, 2008K082364IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR
Topcon Corp.
NFJ
Jun 22, 2007K063388TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM
Topcon Corp.
OBO
Nov 5, 2004K041367TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
Topcon Corp.
HKI

Latest recalls

DateFirm and productCodeLinked 510(k)
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