Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570) → OBO — Tomography, Optical Coherence # OBO · Tomography, Optical Coherence _Ophthalmic · 21 CFR 886.1570 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO ## Overview - **Product Code:** OBO - **Device Name:** Tomography, Optical Coherence - **Regulation:** [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) ## Identification An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. ## Classification Rationale Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Special Controls *Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. ## Recent Cleared Devices (20 of 65) Showing 20 most recent of 65 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252633](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K252633.md) | UNITY DX (UDX) | Cylite Pty. , Ltd. | Dec 23, 2025 | SESE | | [K250553](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K250553.md) | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | Jul 18, 2025 | SESE | | [K250868](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K250868.md) | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | May 12, 2025 | SESE | | [K240924](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K240924.md) | Anterion | Heidelberg Engineering GmbH | Dec 13, 2024 | SESE | | [K241163](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K241163.md) | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | Oct 11, 2024 | SESE | | [K241081](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K241081.md) | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation | Jul 17, 2024 | SESE | | [K240221](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K240221.md) | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | Jul 1, 2024 | SESE | | [K233933](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K233933.md) | CIRRUS™ HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | May 17, 2024 | SESE | | [K233602](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K233602.md) | P200TE (A10700) | Optos Plc. | May 9, 2024 | SESE | | [K233561](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K233561.md) | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | Apr 10, 2024 | SESE | | [K233421](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K233421.md) | RESCAN 700 | Carl Zeiss Meditec, AG | Mar 8, 2024 | SESE | | [K231222](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K231222.md) | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | Oct 30, 2023 | SESE | | [K223557](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K223557.md) | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | Oct 20, 2023 | SESE | | [K230897](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K230897.md) | Anterion | Heidelberg Engineering GmbH | Oct 11, 2023 | SESE | | [K221601](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K221601.md) | MS-39 | C.S.O. S.R.L. | Sep 1, 2023 | SESE | | [K231673](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K231673.md) | P200TE (A10700) | Optos Plc. | Aug 18, 2023 | SESE | | [K222200](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K222200.md) | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | Apr 13, 2023 | SESE | | [K221320](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K221320.md) | Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EX | Nidek Co., Ltd. | Mar 30, 2023 | SESE | | [K222166](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K222166.md) | SOLIX | Optovue, Inc. | Nov 9, 2022 | SESE | | [K213265](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO/K213265.md) | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | Apr 27, 2022 | SESE | ## Top Applicants - Heidelberg Engineering GmbH — 16 clearances - Carl Zeiss Meditec, Inc. — 8 clearances - Optovue, Inc. — 7 clearances - Topcon Corporation — 6 clearances - Optos Plc. — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/OBO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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