FDA Product Code
FDA Product Code OBO — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1570
510(k) Clearances — 67 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261019 | ANTERION | Heidelberg Engineering GmbH | 2026-09-11 | Traditional | PDF ↗ |
| K253837 | SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2026-05-07 | Traditional | PDF ↗ |
| K252633 | UNITY DX (UDX) | Cylite Pty. , Ltd. | 2025-12-23 | Traditional | PDF ↗ |
| K250553 | Tomey Cornea/Anterior Segment OCT (CASIA2) | Tomey Corporation | 2025-07-18 | Traditional | PDF ↗ |
| K250868 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2025-05-12 | Traditional | PDF ↗ |
| K240924 | Anterion | Heidelberg Engineering GmbH | 2024-12-13 | Traditional | PDF ↗ |
| K241163 | SPECTRALIS with Flex Module | Heidelberg Engineering GmbH | 2024-10-11 | Traditional | PDF ↗ |
| K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System | Topcon Corporation | 2024-07-17 | Traditional | PDF ↗ |
| K240221 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2024-07-01 | Traditional | PDF ↗ |
| K233933 | CIRRUS HD-OCT Model 6000 | Carl Zeiss Meditec, Inc. | 2024-05-17 | Traditional | PDF ↗ |
| K233602 | P200TE (A10700) | Optos Plc. | 2024-05-09 | Traditional | PDF ↗ |
| K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024-04-10 | Traditional | PDF ↗ |
| K233421 | RESCAN 700 | Carl Zeiss Meditec, AG | 2024-03-08 | Traditional | PDF ↗ |
| K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023-10-30 | Traditional | PDF ↗ |
| K223557 | SPECTRALIS HRA+OCT and variants | Heidelberg Engineering GmbH | 2023-10-20 | Traditional | PDF ↗ |
| K230897 | Anterion | Heidelberg Engineering GmbH | 2023-10-11 | Traditional | PDF ↗ |
| K221601 | MS-39 | C.S.O. S.R.L. | 2023-09-01 | Traditional | PDF ↗ |
| K231673 | P200TE (A10700) | Optos Plc. | 2023-08-18 | Traditional | PDF ↗ |
| K222200 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2023-04-13 | Traditional | PDF ↗ |
| 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. | 2023-03-30 | Traditional | PDF ↗ |
| K222166 | SOLIX | Optovue, Inc. | 2022-11-09 | Traditional | PDF ↗ |
| K213265 | Tomey Cornea/Anterior Segment OCT CASIA2 | Tomey Corporation | 2022-04-27 | Traditional | PDF ↗ |
| K211817 | Anterion | Heidelberg Engineering GmbH | 2021-11-05 | Traditional | PDF ↗ |
| K201252 | Spectralis HRA+OCT and variants | Heidelberg Engineering GmbH | 2020-09-09 | Traditional | PDF ↗ |
| K200516 | OCT-Camera ID 21101A3 | Optomedical Technologies GmbH | 2020-09-02 | Traditional | PDF ↗ |
| K192391 | Spectralis HRA+OCT and Variants | Heidelberg Engineering GmbH | 2019-09-26 | Special | PDF ↗ |
| K190732 | P200TxE | Optos Plc. | 2019-07-31 | Traditional | PDF ↗ |
| K182942 | Canon OCT-A1 | Canon, Inc. | 2019-07-24 | Traditional | PDF ↗ |
| K181534 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2019-02-15 | Traditional | PDF ↗ |
| K180229 | RESCAN 700, CALLISTO eye | Carl Zeiss Meditec, AG | 2019-01-11 | Traditional | PDF ↗ |
| K182569 | Spectralis HRA+OCT and variants with High Magnification Module | Heidelberg Engineering GmbH | 2018-10-18 | Special | PDF ↗ |
| K181594 | Spectralis HRA+OCT and variants with OCT Angiography Module | Heidelberg Engineering GmbH | 2018-09-13 | Traditional | PDF ↗ |
| K173648 | Spectralis HRA + OCT and variants | Heidelberg Engineering GmbH | 2018-08-30 | Traditional | PDF ↗ |
| K180660 | Avanti | Optovue, Inc. | 2018-06-08 | Traditional | PDF ↗ |
| K173707 | P200TE | Optos Plc. | 2018-02-28 | Traditional | PDF ↗ |
| K173119 | DRI OCT Triton | Topcon Corporation | 2018-01-19 | Traditional | PDF ↗ |
| K172649 | Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor | Heidelberg Engineering GmbH | 2017-11-01 | Special | PDF ↗ |
| K163195 | PRIMUS | Carl Zeiss Suzhou Co., Ltd. | 2017-06-21 | Traditional | PDF ↗ |
| K163475 | iVue | Optovue, Inc. | 2017-06-09 | Traditional | PDF ↗ |
| K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017-03-03 | Special | PDF ↗ |
| K162783 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2016-12-09 | Special | PDF ↗ |
| K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016-10-26 | Traditional | PDF ↗ |
| K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016-07-28 | Traditional | PDF ↗ |
| K152205 | Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor | Heidelberg Engineering GmbH | 2016-05-06 | Traditional | PDF ↗ |
| K150977 | CIRRUS HD-OCT | Carl Zeiss Meditec, Inc. | 2015-09-01 | Traditional | PDF ↗ |
| K141844 | RESCAN 700, CALLISTO EYE | Carl Zeiss Meditec, AG | 2014-11-18 | Traditional | PDF ↗ |
| K133217 | CIRRUS PHOTO | Carl Zeiss Meditec, AG | 2014-03-19 | Traditional | PDF ↗ |
| K132323 | RS-3000 ADVANCE | Nidek Co., Ltd. | 2014-02-19 | Traditional | PDF ↗ |
| K121622 | NIDEK RS-3000 | Nidek Co., Ltd. | 2013-03-14 | Traditional | PDF ↗ |
| K121043 | OPTOS OCT/SLO MICROPERIMETER | Optos Plc. | 2013-02-22 | Traditional | PDF ↗ |
| K121993 | SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT | Heidelberg Engineering GmbH | 2012-10-25 | Traditional | PDF ↗ |
| K112184 | CIRRUS PHOTO | Carl Zeiss Meditec, Inc. | 2012-06-18 | Traditional | PDF ↗ |
| K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES | Carl Zeiss Meditec, Inc. | 2012-01-19 | Traditional | PDF ↗ |
| K113129 | SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) | Heidelberg Engineering GmbH | 2011-11-08 | Traditional | PDF ↗ |
| K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | Optovue, Inc. | 2011-09-08 | Traditional | PDF ↗ |
| K101223 | SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA | Heidelberg Engineering | 2010-10-01 | Traditional | PDF ↗ |
| K091404 | IVUE, MODEL 100 | Optovue, Inc. | 2010-04-22 | Traditional | PDF ↗ |
| K092470 | OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 | Topcon Corp. | 2009-09-02 | Special | PDF ↗ |
| K083291 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 | Carl Zeiss Meditec, Inc. | 2009-05-05 | Traditional | PDF ↗ |
| K083316 | 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Topcon Medical Systems, Inc. | 2009-03-13 | Traditional | PDF ↗ |
| K072971 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS | Topcon Medical Systems, Inc. | 2009-01-13 | Traditional | PDF ↗ |
| K080460 | SPECTRAL OCT/SLO | Opko Health, Inc. | 2008-11-14 | Traditional | PDF ↗ |
| K071839 | SOCT COPERNICUS, MODEL 15205 | Reichert, Inc. | 2008-02-27 | Traditional | PDF ↗ |
| K071250 | CA, MODEL: CAM | Optovue, Inc. | 2007-09-28 | Traditional | PDF ↗ |
| K063388 | TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM | Topcon Corp. | 2007-06-22 | Traditional | PDF ↗ |
| K063191 | HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT | Heidelberg Engineering | 2006-10-31 | Traditional | PDF ↗ |
| K062552 | RTVUE | Optovue, Inc. | 2006-10-06 | Traditional | PDF ↗ |
Product code OBO · Class II · Ophthalmic. Data: openFDA.