Topcon Corporation
Medical device manufacturer in Tokyo, JP.
22510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253039 | Auto Kerato-Refracto Tonometer TRK-3 OmniaHKX · Traditional | 11/07/2025SE |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional | 07/17/2024SE |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))OBO · Traditional | 04/10/2024SE |
| K232828 | IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional | 03/01/2024SE |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)OBO · Traditional | 10/30/2023SE |
| K221111 | Non-Mydriatic Retinal Camera NW500HKI · Traditional | 08/29/2022SE |
| K173119 | DRI OCT TritonOBO · Traditional | 01/19/2018SE |
| K171370 | IMAGEnet 6 Ophthalmic Data SystemNFJ · Traditional | 11/01/2017SE |
| K170164 | 3D OCT-1 MaestroOBO · Special | 03/03/2017SE |
| K161972 | Slit Lamp SL-D301HJO · Traditional | 12/09/2016SE |
| K161509 | 3D OCT-1 MaestroOBO · Traditional | 07/28/2016SE |
| K142417 | SP-1PSpecular MicroscopeNQE · Traditional | 05/29/2015SE |
| K141325 | TRC-NW8F Plus Non-Mydriatic Retinal CameraHKI · Traditional | 10/23/2014SE |
| K141481 | TRC-NW400 Non-Mydriatic Retinal CameraHKI · Traditional | 09/17/2014SE |
| K133667 | Slit Lamp SL-D701HJO · Traditional | 08/26/2014SE |
| K130289 | TRC-NW8 Non-Mydriatic Retinal CameraHKI · Special | 05/10/2013SE |
| K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8FHKI · Traditional | 02/12/2010SE |
| K092470 | Optical Coherence Tomography 3D OCT-2000OBO · Special | 09/02/2009SE |
| K090115 | Retina Camera TRC-NW7SF Mark IIHKI · Traditional | 06/30/2009SE |
| K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet Pro, or…NFJ · Traditional | 09/30/2008SE |
| K063388 | Topcon 3D OCT-1000 Optical Coherence Tomography SystemOBO · Traditional | 06/22/2007SE |
| K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraHKI · Traditional | 11/05/2004SE |