Topcon Corporation - FDA 510(k) Cleared Devices

Cleared Nov 07, 2025

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

K253039 · HKX

Ophthalmic · 46d

Cleared CT Jul 17, 2024

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)

K241081 · OBO

Ophthalmic · 89d

Cleared Apr 10, 2024

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))

K233561 · OBO

Ophthalmic · 156d

Cleared Mar 01, 2024

IMAGEnet6 Ophthalmic Data System

K232828 · NFJ

Ophthalmic · 170d

Cleared Oct 30, 2023

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)

K231222 · OBO

Ophthalmic · 185d

Cleared Aug 29, 2022

Non-Mydriatic Retinal Camera NW500

K221111 · HKI

Ophthalmic · 136d

Cleared CT Jan 19, 2018

DRI OCT Triton

K173119 · OBO

Ophthalmic · 112d

Cleared Nov 01, 2017

IMAGEnet 6 Ophthalmic Data System

K171370 · NFJ

Ophthalmic · 175d

Cleared Mar 03, 2017

3D OCT-1 Maestro

K170164 · OBO

Ophthalmic · 44d

Cleared Dec 09, 2016

Slit Lamp SL-D301

K161972 · HJO

Ophthalmic · 144d

Cleared Jul 28, 2016

3D OCT-1 Maestro

K161509 · OBO

Ophthalmic · 57d

Cleared May 29, 2015

SP-1PSpecular Microscope

K142417 · NQE

Ophthalmic · 274d

Cleared Sep 17, 2014

TRC-NW400 NON-MYDRIATIC RETINAL CAMERA

K141481 · HKI

Ophthalmic · 105d