Topcon Corporation FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
SLIT LAMP SL-D4 (Type: LED)510(k)Sep 18, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Sep 18, 2026
AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA510(k)Nov 7, 2025Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Nov 7, 2025
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System510(k)Jul 17, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jul 17, 2024
3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))510(k)Apr 10, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Apr 10, 2024
IMAGEnet6 Ophthalmic Data System510(k)Mar 1, 2024Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Mar 1, 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)510(k)Oct 30, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Oct 30, 2023
Non-Mydriatic Retinal Camera NW500510(k)Aug 29, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Aug 29, 2022