Tokyo, JP · 7 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| OBO | Tomography, Optical Coherence | Class II | Ophthalmic | 3 | 2024-07-17 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Class II | Ophthalmic | 1 | 2026-09-18 |
| HKX | Tonometer, Ac-Powered | Class II | Ophthalmic | 1 | 2025-11-07 |
| NFJ | System, Image Management, Ophthalmic | Class II | Radiology | 1 | 2024-03-01 |
| HKI | Camera, Ophthalmic, Ac-Powered | Class II | Ophthalmic | 1 | 2022-08-29 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-09-18 | K262637 | SLIT LAMP SL-D4 (Type: LED) | HJO | Class II | Ophthalmic |
| 2025-11-07 | K253039 | AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA | HKX | Class II | Ophthalmic |
| 2024-07-17 | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | OBO | Class II | Ophthalmic |
| 2024-04-10 | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | OBO | Class II | Ophthalmic |
| 2024-03-01 | K232828 | IMAGEnet6 Ophthalmic Data System | NFJ | Class II | Radiology |
| 2023-10-30 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | OBO | Class II | Ophthalmic |
| 2022-08-29 | K221111 | Non-Mydriatic Retinal Camera NW500 | HKI | Class II | Ophthalmic |