Topcon Corporation is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Topcon Corporation - FDA 510(k) Cleared Devices
Recent clearances: AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA, 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2), 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
13
Total
13
Cleared
0
Denied
Topcon Corporation has 13 FDA 510(k) cleared ophthalmic devices. Based in North Reading, US.
Latest FDA clearance: Nov 2025. Active since 2014.
Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Orasi Consulting, Boston Medtech Advisors, Inc. and Oconnell Regulatory Consultants, Inc.. 2 devices have linked clinical trials registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Topcon Corporation
13 devices
Cleared
Nov 07, 2025
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA
Ophthalmic
46d
Cleared
CT
Jul 17, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
Ophthalmic
89d
Cleared
Apr 10, 2024
3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))
Ophthalmic
156d
Cleared
Mar 01, 2024
IMAGEnet6 Ophthalmic Data System
Ophthalmic
170d
Cleared
Oct 30, 2023
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Ophthalmic
185d
Cleared
Aug 29, 2022
Non-Mydriatic Retinal Camera NW500
Ophthalmic
136d
Cleared
CT
Jan 19, 2018
DRI OCT Triton
Ophthalmic
112d
Cleared
Nov 01, 2017
IMAGEnet 6 Ophthalmic Data System
Ophthalmic
175d
Cleared
Mar 03, 2017
3D OCT-1 Maestro
Ophthalmic
44d
Cleared
Dec 09, 2016
Slit Lamp SL-D301
Ophthalmic
144d
Cleared
Jul 28, 2016
3D OCT-1 Maestro
Ophthalmic
57d
Cleared
May 29, 2015
SP-1PSpecular Microscope
Ophthalmic
274d
Cleared
Sep 17, 2014
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
Ophthalmic
105d