OBO
- Product code
- OBO
- Device name
- Tomography, Optical Coherence
- Device class
- Class 2
- 21 CFR
- 21 CFR 886.1570
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 15
- Summaries archived here
- 14 (direct download)
- 510(k) clearances (all years, FDA)
- 66 (all years; only the last 3 years are listed here)
FDA classification definition
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
510(k) clearances, last 3 years (15)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253837 | 2026-05-07 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Fle… | FDA |
| K252633 | 2025-12-23 | Cylite Pty. , Ltd. | UNITY DX (UDX) | |
| K250553 | 2025-07-18 | Tomey Corporation | Tomey Cornea/Anterior Segment OCT (CASIA2) | |
| K250868 | 2025-05-12 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants | |
| K240924 | 2024-12-13 | Heidelberg Engineering GmbH | Anterion | |
| K241163 | 2024-10-11 | Heidelberg Engineering GmbH | SPECTRALIS with Flex Module | |
| K241081 | 2024-07-17 | Topcon Corporation | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maes… | |
| K240221 | 2024-07-01 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants | |
| K233933 | 2024-05-17 | Carl Zeiss Meditec, Inc. | CIRRUS HD-OCT Model 6000 | |
| K233602 | 2024-05-09 | Optos Plc. | P200TE (A10700) | |
| K233561 | 2024-04-10 | Topcon Corporation | 3D Optical Coherence Tomography (3D OCT-1(type: Maes… | |
| K233421 | 2024-03-08 | Carl Zeiss Meditec, AG | RESCAN 700 | |
| K231222 | 2023-10-30 | Topcon Corporation | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maest… | |
| K223557 | 2023-10-20 | Heidelberg Engineering GmbH | SPECTRALIS HRA+OCT and variants | |
| K230897 | 2023-10-11 | Heidelberg Engineering GmbH | Anterion |
Official FDA classification page: OBO
Classification and pathway per current FDA publications. Data from openFDA (CC0).