Medical Device Manufacturer · US , North Reading , MA

Topcon Corporation

13 submissions · 13 cleared · Since 2014

13

Total

13

Cleared

0

Denied

Topcon Corporation — FDA 510(k) Submissions

Topcon Corporation has submitted 13 FDA 510(k) premarket notifications since 2014, of which 13 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tomography, Optical Coherence, System, Image Management, Ophthalmic, Camera, Ophthalmic, Ac-powered, Biomicroscope, Slit-lamp, Ac-powered, Tonometer, Ac-powered . Use the specialty filter in the sidebar to narrow results.

13 devices

1–13 of 13

AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA

K253039 · HKX Tonometer, Ac-powered · Ophthalmic

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System

K241081 · OBO Tomography, Optical... · Ophthalmic

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

K233561 · OBO Tomography, Optical... · Ophthalmic

IMAGEnet6 Ophthalmic Data System

K232828 · NFJ System, Image Management,... · Ophthalmic

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

K231222 · OBO Tomography, Optical... · Ophthalmic

Non-Mydriatic Retinal Camera NW500

K221111 · HKI Camera, Ophthalmic,... · Ophthalmic

K173119 · OBO Tomography, Optical... · Ophthalmic

IMAGEnet 6 Ophthalmic Data System

K171370 · NFJ System, Image Management,... · Ophthalmic

3D OCT-1 Maestro

K170164 · OBO Tomography, Optical... · Ophthalmic

Slit Lamp SL-D301

K161972 · HJO Biomicroscope, Slit-lamp,... · Ophthalmic

3D OCT-1 Maestro

K161509 · OBO Tomography, Optical... · Ophthalmic

SP-1PSpecular Microscope

K142417 · NQE Microscope, Specular · Ophthalmic

TRC-NW400 NON-MYDRIATIC RETINAL CAMERA

K141481 · HKI Camera, Ophthalmic,... · Ophthalmic