OBO — Tomography, Optical Coherence Class II
FDA product code OBO covers "Tomography, Optical Coherence", a Class II medical device regulated under 21 CFR 886.1570. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OBO
- Device Class
- Class II
- Regulation Number
- 886.1570
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253837 | heidelberg engineering | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | May 7, 2026 |
| K252633 | cylite pty. | UNITY DX (UDX) | December 23, 2025 |
| K250553 | tomey corporation | Tomey Cornea/Anterior Segment OCT (CASIA2) | July 18, 2025 |
| K250868 | heidelberg engineering | SPECTRALIS HRA+OCT and variants | May 12, 2025 |
| K240924 | heidelberg engineering | Anterion | December 13, 2024 |
| K241163 | heidelberg engineering | SPECTRALIS with Flex Module | October 11, 2024 |
| K241081 | topcon corporation | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic | July 17, 2024 |
| K240221 | heidelberg engineering | SPECTRALIS HRA+OCT and variants | July 1, 2024 |
| K233933 | carl zeiss meditec | CIRRUS HD-OCT Model 6000 | May 17, 2024 |
| K233602 | optos | P200TE (A10700) | May 9, 2024 |
| K233561 | topcon corporation | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | April 10, 2024 |
| K233421 | carl zeiss meditec | RESCAN 700 | March 8, 2024 |
| K231222 | topcon corporation | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | October 30, 2023 |
| K223557 | heidelberg engineering | SPECTRALIS HRA+OCT and variants | October 20, 2023 |
| K230897 | heidelberg engineering | Anterion | October 11, 2023 |
| K221601 | c.s.o | MS-39 | September 1, 2023 |
| K231673 | optos | P200TE (A10700) | August 18, 2023 |
| K222200 | carl zeiss meditec | CIRRUS HD-OCT | April 13, 2023 |
| K221320 | nidek co | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software | March 30, 2023 |
| K222166 | optovue | SOLIX | November 9, 2022 |