TOPCON CORP.

FDA Device Registration & Listing · TOKYO, JP · Registration 9614661

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9614661
FEI Number
1000175127
Entity Name
TOPCON CORP.
City/State/Country
TOKYO, JP
Establishment Address
75-1 HASUNUMA-CHO, ITABASHI-KU, TOKYO 174-8580, JP
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Topcon Healthcare, Inc. (Owner Number: 9031569)
Owner / Operator Contact Address
111 Bauer Drive, Oakland, NJ 07436, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K092470
PMA Number
N/A

All Registered Proprietary Names

ACP-8 ACP-8R 3D OCT-1 Maestro 3D OCT-1 (Type:Maestro2) NW500 TRC-NW8F SL-D701 SL-D2 SL-D4 SL-D7 SL-3G SL-D8Z SL-1E SL-D4 (Type:LED) IMAGEnet 6 IMAGEnet 7 IMAGEnet 6 SL-2G TRC-50DX PD-5 OMS-90 OMS-710 OMS-800 SL-D301 CT-80 TRC-NW8F plus SP-1P 3D OPTICAL COHERENCE TOMOGRAPHY (3D OCT-1(type: Maestro2)) IMAGEnet6 Ophthalmic Data System TLS-AF TLS LM-8; LM-8E; CL-200; EZ-200 CL-300 DRI OCT Triton (plus) DRI OCT Triton SP-3000P SS-3 MC-4S MIRROR CHART MC-5S PC-50S TRC-NW300 IMAGEnet6 TRK-3 OMNIA TRC-NW400 TRC-NW8 OM-4 3D OCT-1000 VT-10 CV-5000 TRC-NW7SF MARK II IMAGEnet 5 CT-800 CT-1P CT-1 TRK-1P TRK-2P CT-800A TRK-3 OMNIA NW500 3D OCT-1000 MARK II 3D OCT-2000

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HOS Projector, Ophthalmic Ophthalmic Class 1 886.1680 2003-10-06
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2017-03-06
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2017-03-06
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2022-08-29
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2010-03-25
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2014-09-02
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2009-11-05
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2017-01-24
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2017-11-02
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2017-11-02
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2017-11-02
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2011-11-22
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-06-17
HLH Pupillometer, Manual Ophthalmic Class 1 886.1700 2003-10-06
HRM Microscope, Operating & Accessories, Ac-Powered, Ophthalmic General, Plastic Surgery Class 1 878.4700 2003-10-06
HJO Biomicroscope, Slit-Lamp, Ac-Powered Ophthalmic Class 2 886.1850 2016-12-09
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2008-10-21
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2014-10-27
NQE Microscope, Specular Ophthalmic Class 2 886.1850 2015-06-01
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2024-08-02
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2024-08-02
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2024-08-02
HPC Set, Lens, Trial, Ophthalmic Ophthalmic Class 1 886.1405 1997-09-15
HLM Instrument, Measuring, Lens, Ac-Powered Ophthalmic Class 1 886.1425 2003-10-06
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2018-01-19
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2018-01-19
NQE Microscope, Specular Ophthalmic Class 2 886.1850 2016-06-17
HOX Chart, Visual Acuity Ophthalmic Class 1 886.1150 2011-11-22
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-03-01
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2024-03-21
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2024-03-21
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2024-03-21
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2025-11-14
MXK Device, Analysis, Anterior Segment Ophthalmic Class 2 886.1850 2025-11-14
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2014-10-27
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2013-05-20
HJB Instrument, Measuring, Corneal Radius Ophthalmic Class 1 886.1450 2003-10-06
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2009-11-19
HKN Refractor, Manual, Non-Powered, Including Phoropter Ophthalmic Class 1 886.1770 2003-10-06
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2009-11-05
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2013-11-13
HKX Tonometer, Ac-Powered Ophthalmic Class 2 886.1930 2016-06-17
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2022-08-31
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2009-11-04
OBO Tomography, Optical Coherence Ophthalmic Class 2 886.1570 2009-11-04

Official Correspondent

No official correspondent registered.

US Agent Details

Susan Quick Business: Topcon Healthcare, Inc. Email: tmsregulatory@topcon.com Phone: (216) 7805532

Related Public Records

Same Entity

Topcon Healthcare, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3002808383 Topcon Yamagata Co., LTD West Factory Yamagata-ken, JP
2242863 Topcon Healthcare, Inc. Oakland, NJ, US
3008729548 Topcon Yamagata Co., LTD Yamagata-KEN, JP

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K041546 Canon, Inc. DIGITAL FUNDUS CAMERA, MODEL CF-60DSI 2004-06-23
K870750 Keeler Instruments, Inc. KEELER PULSAIR NON CONTACT TONOMETER 1987-03-17
K900478 Woodlyn, Inc. WOODLYN FULL APERTURE TRIAL LENS SET 1990-02-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0024-2013 Optovue Inc. 2
Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease.
Z-0009-2018 Optovue, Inc. 2
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is suitable for photographing, displaying and storing images of the retina and external areas of the eye to be evaluated under non-mydriatic conditions. The iCam takes digital images of the posterior and external structures of the eye without the use of a mydriatic agent and is intended for use as an aid to clinicians in the evaluation, diagnosis and documentation of ocular health. iCam provides images only and does not provide any diagnostic, pathological analysis or classification of ocular health or disease. AND iVue with Normative Database (K121739) - The iVue is a noncontact, high resolution optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior. ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, and anterior chamber of the eye. The iVue with Normative Database is a quantitative tool for comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9614661. Last updated year: 2026. Please use registration number 9614661 when referencing this establishment in official correspondence.
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