Topcon Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
1
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIANovember 7, 2025
K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data SystemJuly 17, 2024
K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))April 10, 2024
K232828IMAGEnet6 Ophthalmic Data SystemMarch 1, 2024
K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)October 30, 2023
K221111Non-Mydriatic Retinal Camera NW500August 29, 2022
K173119DRI OCT TritonJanuary 19, 2018
K171370IMAGEnet 6 Ophthalmic Data SystemNovember 1, 2017
K1701643D OCT-1 MaestroMarch 3, 2017
K161972Slit Lamp SL-D301December 9, 2016
K1615093D OCT-1 MaestroJuly 28, 2016
K142417SP-1PSpecular MicroscopeMay 29, 2015
K141481TRC-NW400 NON-MYDRIATIC RETINAL CAMERASeptember 17, 2014