OBO · Tomography, Optical Coherence
Ophthalmic · 21 CFR 886.1570 · Class 2
Overview
| Product Code | OBO |
|---|---|
| Device Name | Tomography, Optical Coherence |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
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 | UNITY DX (UDX) | Cylite Pty. , Ltd. | Dec 23, 2025 | SESE |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | Jul 18, 2025 | SESE |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | May 12, 2025 | SESE |
| K240924 | Anterion | Heidelberg Engineering GmbH | Dec 13, 2024 | SESE |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | Oct 11, 2024 | SESE |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation | Jul 17, 2024 | SESE |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | Jul 1, 2024 | SESE |
| K233933 | CIRRUS HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | May 17, 2024 | SESE |
| K233602 | P200TE (A10700) | Optos Plc. | May 9, 2024 | SESE |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | Apr 10, 2024 | SESE |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | Mar 8, 2024 | SESE |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | Oct 30, 2023 | SESE |
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | Oct 20, 2023 | SESE |
| K230897 | Anterion | Heidelberg Engineering GmbH | Oct 11, 2023 | SESE |
| K221601 | MS-39 | C.S.O. S.R.L. | Sep 1, 2023 | SESE |
| K231673 | P200TE (A10700) | Optos Plc. | Aug 18, 2023 | SESE |
| K222200 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | Apr 13, 2023 | SESE |
| K221320 | 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 | SOLIX | Optovue, Inc. | Nov 9, 2022 | SESE |
| K213265 | 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
