| SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (K253837) | Heidelberg Engineering GmbH | 2026-05-07 |
| UNITY DX (UDX) (K252633) | Cylite Pty. , Ltd. | 2025-12-23 |
| Tomey Cornea/Anterior Segment OCT (CASIA2) (K250553) | Tomey Corporation | 2025-07-18 |
| SPECTRALIS HRA+OCT and variants (K250868) | Heidelberg Engineering GmbH | 2025-05-12 |
| Anterion (K240924) | Heidelberg Engineering GmbH | 2024-12-13 |
| SPECTRALIS with Flex Module (K241163) | Heidelberg Engineering GmbH | 2024-10-11 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System (K241081) | Topcon Corporation | 2024-07-17 |
| SPECTRALIS HRA+OCT and variants (K240221) | Heidelberg Engineering GmbH | 2024-07-01 |
| CIRRUS™ HD-OCT Model 6000 (K233933) | Carl Zeiss Meditec, Inc. | 2024-05-17 |
| P200TE (A10700) (K233602) | Optos Plc. | 2024-05-09 |
| 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (K233561) | Topcon Corporation | 2024-04-10 |
| RESCAN 700 (K233421) | Carl Zeiss Meditec, AG | 2024-03-08 |
| 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) (K231222) | Topcon Corporation | 2023-10-30 |
| SPECTRALIS HRA+OCT and variants (K223557) | Heidelberg Engineering GmbH | 2023-10-20 |
| Anterion (K230897) | Heidelberg Engineering GmbH | 2023-10-11 |
| MS-39 (K221601) | C.S.O. S.R.L. | 2023-09-01 |
| P200TE (A10700) (K231673) | Optos Plc. | 2023-08-18 |
| CIRRUS HD-OCT (K222200) | Carl Zeiss Meditec, Inc. | 2023-04-13 |
| 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 (K221320) | Nidek Co., Ltd. | 2023-03-30 |
| SOLIX (K222166) | Optovue, Inc. | 2022-11-09 |
| Tomey Cornea/Anterior Segment OCT CASIA2 (K213265) | Tomey Corporation | 2022-04-27 |
| Anterion (K211817) | Heidelberg Engineering GmbH | 2021-11-05 |
| Spectralis HRA+OCT and variants (K201252) | Heidelberg Engineering GmbH | 2020-09-09 |
| OCT-Camera ID 21101A3 (K200516) | Optomedical Technologies GmbH | 2020-09-02 |
| Spectralis HRA+OCT and Variants (K192391) | Heidelberg Engineering GmbH | 2019-09-26 |
| P200TxE (K190732) | Optos Plc. | 2019-07-31 |
| Canon OCT-A1 (K182942) | Canon, Inc. | 2019-07-24 |
| CIRRUS HD-OCT (K181534) | Carl Zeiss Meditec, Inc. | 2019-02-15 |
| RESCAN 700, CALLISTO eye (K180229) | Carl Zeiss Meditec, AG | 2019-01-11 |
| Spectralis HRA+OCT and variants with High Magnification Module (K182569) | Heidelberg Engineering GmbH | 2018-10-18 |
| Spectralis HRA+OCT and variants with OCT Angiography Module (K181594) | Heidelberg Engineering GmbH | 2018-09-13 |
| Spectralis HRA + OCT and variants (K173648) | Heidelberg Engineering GmbH | 2018-08-30 |
| Avanti (K180660) | Optovue, Inc. | 2018-06-08 |
| P200TE (K173707) | Optos Plc. | 2018-02-28 |
| DRI OCT Triton (K173119) | Topcon Corporation | 2018-01-19 |
| Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor (K172649) | Heidelberg Engineering GmbH | 2017-11-01 |
| PRIMUS (K163195) | Carl Zeiss Suzhou Co., Ltd. | 2017-06-21 |
| iVue (K163475) | Optovue, Inc. | 2017-06-09 |
| 3D OCT-1 Maestro (K170164) | Topcon Corporation | 2017-03-03 |
| EnFocus 2300, EnFocus 4400 (K162783) | Bioptigen, Inc. | 2016-12-09 |
| PLEX Elite 9000 SS-OCT (K161194) | Carl Zeiss Meditec, Inc. | 2016-10-26 |
| 3D OCT-1 Maestro (K161509) | Topcon Corporation | 2016-07-28 |
| Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT ith Multicolor (K152205) | Heidelberg Engineering GmbH | 2016-05-06 |
| CIRRUS HD-OCT (K150977) | Carl Zeiss Meditec, Inc. | 2015-09-01 |
| RESCAN 700, CALLISTO EYE (K141844) | Carl Zeiss Meditec, AG | 2014-11-18 |
| CIRRUS PHOTO (K133217) | Carl Zeiss Meditec, AG | 2014-03-19 |
| RS-3000 ADVANCE (K132323) | Nidek Co., Ltd. | 2014-02-19 |
| NIDEK RS-3000 (K121622) | Nidek Co., Ltd. | 2013-03-14 |
| OPTOS OCT/SLO MICROPERIMETER (K121043) | Optos Plc. | 2013-02-22 |
| SPECTRALIS HRA + OCT AND VARIANTS, SPECTRALIS FA+ OCT, SPECTRALIS ICGA +OCT, SPECTRALIS OCT BLUE PEAK, SPECTRALIS OCT (K121993) | Heidelberg Engineering GmbH | 2012-10-25 |
| CIRRUS PHOTO (K112184) | Carl Zeiss Meditec, Inc. | 2012-06-18 |
| CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (K111157) | Carl Zeiss Meditec, Inc. | 2012-01-19 |
| SPECTRALIS ANTERIOR SEGMENT MODULE (SPECTRALIS ASM) (K113129) | Heidelberg Engineering GmbH | 2011-11-08 |
| RTVUE CAM WITH CORNEAL POWER UPGRADE (K111505) | Optovue, Inc. | 2011-09-08 |
| SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA (K101223) | Heidelberg Engineering | 2010-10-01 |
| IVUE, MODEL 100 (K091404) | Optovue, Inc. | 2010-04-22 |
| OPTICAL COHERENCE TOMOGRAPHY 3D OCT-2000 (K092470) | Topcon Corp. | 2009-09-02 |
| CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 (K083291) | Carl Zeiss Meditec, Inc. | 2009-05-05 |
| 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM (K083316) | Topcon Medical Systems, Inc. | 2009-03-13 |
| TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM FOR MEASUREMENT OF RETINAL THICKNESS (K072971) | Topcon Medical Systems, Inc. | 2009-01-13 |
| SPECTRAL OCT/SLO (K080460) | Opko Health, Inc. | 2008-11-14 |
| SOCT COPERNICUS, MODEL 15205 (K071839) | Reichert, Inc. | 2008-02-27 |
| CA, MODEL: CAM (K071250) | Optovue, Inc. | 2007-09-28 |
| TOPCON 3D OCT-1000 OPTICAL COHERENCE TOMOGRAPHY SYSTEM (K063388) | Topcon Corp. | 2007-06-22 |
| HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT (K063191) | Heidelberg Engineering | 2006-10-31 |
| RTVUE (K062552) | Optovue, Inc. | 2006-10-06 |