Topcon Corporation
FDA 510(k) & PMA Approved Devices — 11 products
Total Devices11
Categories5
Latest FDA decision2025-11-07
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | HKX | 2025-11-07 | View |
| 510(k) | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | OBO | 2024-07-17 | View |
| 510(k) | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | OBO | 2024-04-10 | View |
| 510(k) | K232828 | IMAGEnet6 Ophthalmic Data System | NFJ | 2024-03-01 | View |
| 510(k) | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | OBO | 2023-10-30 | View |
| 510(k) | K221111 | Non-Mydriatic Retinal Camera NW500 | HKI | 2022-08-29 | View |
| 510(k) | K173119 | DRI OCT Triton | OBO | 2018-01-19 | View |
| 510(k) | K171370 | IMAGEnet 6 Ophthalmic Data System | NFJ | 2017-11-01 | View |
| 510(k) | K170164 | 3D OCT-1 Maestro | OBO | 2017-03-03 | View |
| 510(k) | K161972 | Slit Lamp SL-D301 | HJO | 2016-12-09 | View |
| 510(k) | K161509 | 3D OCT-1 Maestro | OBO | 2016-07-28 | View |
No matching devices.