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Data / Medical devices / Japan / Topcon Corp.

Topcon Corp.: FDA-registered device maker in Tokyo, Japan, 27 510(k) clearances

Topcon Corp. is registered with the FDA (registration 9614661) in Tokyo, Japan. It lists 19 device types. The FDA files 27 510(k) clearances under its listings, the newest dated September 18, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Topcon Corp.
FDA registration number
9614661
FEI number
1000175127
Address
75-1 Hasunuma-Cho Itabashi-Ku, Tokyo, Japan, 174-8580
Owner or operator
Topcon Healthcare, Inc. (9031569)
Roles
Specification developer
First device listed
September 15, 1997
Registered through
2027
Brand names listed
3D OCT-1 (Type:Maestro2), 3D OCT-1 Maestro, 3D OCT-1(type: Maestro2), 3D OCT-1000, 3D OCT-1000 MARK II, 3D OCT-2000, 3D OCT-2000 (50k), 3D OCT-2000 FA and more

Devices it lists

DeviceProduct codeClassRoleSource
Biomicroscope, Slit-Lamp, Ac-PoweredHJO2Specification developeraccessdata.fda.gov
Camera, Ophthalmic, Ac-PoweredHKI2Specification developeraccessdata.fda.gov
Camera, Ophthalmic, Slit-ScanningQER2Specification developeraccessdata.fda.gov
Chart, Visual AcuityHOX1Specification developeraccessdata.fda.gov
Device, Analysis, Anterior SegmentMXK2Specification developeraccessdata.fda.gov
Frame, Trial, OphthalmicHPA1Specification developeraccessdata.fda.gov
Instrument, Measuring, Corneal RadiusHJB1Specification developeraccessdata.fda.gov
Instrument, Measuring, Lens, Ac-PoweredHLM1Specification developeraccessdata.fda.gov
Microscope, Operating & Accessories, Ac-Powered, OphthalmicHRM1Specification developeraccessdata.fda.gov
Microscope, SpecularNQE2Specification developeraccessdata.fda.gov
Projector, OphthalmicHOS1Specification developeraccessdata.fda.gov
Pupillometer, ManualHLH1Specification developeraccessdata.fda.gov
Refractometer, OphthalmicHKO1Specification developeraccessdata.fda.gov
Refractor, Manual, Non-Powered, Including PhoropterHKN1Specification developeraccessdata.fda.gov
Set, Lens, Trial, OphthalmicHPC1Specification developeraccessdata.fda.gov
System, Image Management, OphthalmicNFJ2Specification developeraccessdata.fda.gov
Table, Instrument, Powered, OphthalmicHRJ1Specification developeraccessdata.fda.gov
Tomography, Optical CoherenceOBO2Specification developeraccessdata.fda.gov
Tonometer, Ac-PoweredHKX2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
September 18, 2026K262637SLIT LAMP SL-D4 (Type: LED)HJOSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
November 7, 2025K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIAHKXSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
July 17, 2024K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemOBOSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
April 10, 2024K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))OBOSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
March 1, 2024K232828IMAGEnet6 Ophthalmic Data SystemNFJSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
August 29, 2022K221111Non-Mydriatic Retinal Camera NW500HKISubstantially EquivalentTopcon Corporationaccessdata.fda.gov
January 19, 2018K173119DRI OCT TritonOBOSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
November 1, 2017K171370IMAGEnet 6 Ophthalmic Data SystemNFJSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
March 3, 2017K1701643D OCT-1 MaestroOBOSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
December 9, 2016K161972Slit Lamp SL-D301HJOSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
July 28, 2016K1615093D OCT-1 MaestroOBOSubstantially EquivalentTopcon Corporationaccessdata.fda.gov
May 29, 2015K142417SP-1PSpecular MicroscopeNQESubstantially EquivalentTopcon Corporationaccessdata.fda.gov
October 23, 2014K141325TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERAHKISubstantially EquivalentTopcon Corp.accessdata.fda.gov
September 17, 2014K141481TRC-NW400 NON-MYDRIATIC RETINAL CAMERAHKISubstantially EquivalentTopcon Corporationaccessdata.fda.gov
August 26, 2014K133667SLIT LAMP SL-D701HJOSubstantially EquivalentTopcon Corp.accessdata.fda.gov
October 17, 2013K132438IMAGENET 5 PC SOFTWARE SYSTEMNFJSubstantially EquivalentTopcon Medical Systems, Inc.accessdata.fda.gov
June 5, 2013K123101TRC-50DX RETINAL CAMERAHKISubstantially EquivalentTopcon Medical Systems, Inc.accessdata.fda.gov
May 10, 2013K130289TRC-NW8 NON-MYDRIATIC RETINAL CAMERAHKISubstantially EquivalentTopcon Corp.accessdata.fda.gov
February 6, 2013K123460TRC-NW300 NON-MYDRIATIC RETINAL CAMERAHKISubstantially EquivalentTopcon Medical Systems, Inc.accessdata.fda.gov
May 23, 2011K110489SLIT LAMP SL-2GHJOSubstantially EquivalentTopcon Medical Systems, Inc.accessdata.fda.gov
February 12, 2010K100207NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8FHKISubstantially EquivalentTopcon Corp.accessdata.fda.gov
September 2, 2009K092470OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000OBOSubstantially EquivalentTopcon Corp.accessdata.fda.gov
June 30, 2009K090115RETINA CAMERA TRC-NW7SF MARK IIHKISubstantially EquivalentTopcon Corp.accessdata.fda.gov
March 13, 2009K0833163D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEMOBOSubstantially EquivalentTopcon Medical Systems, Inc.accessdata.fda.gov
January 13, 2009K072971TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESSOBOSubstantially EquivalentTopcon Medical Systems, Inc.accessdata.fda.gov
September 30, 2008K082364IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FORNFJSubstantially EquivalentTopcon Corp.accessdata.fda.gov
May 18, 1987K871335TOPCON COMPUTERIZED TONOMETER CT-10HKXSubstantially EquivalentTopcon Instrument Corporation of Americaaccessdata.fda.gov

Compare with other makers

Updated September 18, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.