| TearView (K253176) | Beyond 700 Pty, Ltd. | 2026-06-22 |
| Eyer 2 (K251353) | Phelcom Technologies | 2026-01-16 |
| Fundus On Phone Non Mydriatic (FOP NM-10) (K252120) | Remidio Innovative Solutions Private Limited | 2025-12-12 |
| Optina-4C (MHRC-C1N) (K250770) | Optina Diagnostics, Inc. | 2025-09-04 |
| 3nethra neo HD FA; 3nethra neo HD (K243600) | Forus Health Pvt.Ltd | 2025-08-14 |
| Resolve Fundus Camera (K250683) | Optain Health, Inc. | 2025-04-30 |
| Sentinel Camera (K243664) | Ai Optics | 2024-12-17 |
| Verily Numetric Retinal Camera (K242508) | Verily Life Sciences, LLC | 2024-12-09 |
| CANON Fundus Camera CR-10 (CR-10) (K241049) | Canon, Inc. | 2024-05-15 |
| Optina-4C (MHRC-C1N) (K231230) | Optina Diagnostics, Inc. | 2023-12-05 |
| Zilia Ocular FC (ZIL-10002) (K230627) | Zilia, Inc. | 2023-11-20 |
| Phoenix ICON, Phoenix ICON GO (K223575) | Neolight, LLC | 2023-09-06 |
| iExaminer System with Panoptic Plus (K223381) | Welch Allyn, Inc. | 2023-03-15 |
| Eyer Retinal Camera NM-STD (K221329) | Phelcom Technologies | 2023-02-22 |
| Non-Mydriatic Retinal Camera NW500 (K221111) | Topcon Corporation | 2022-08-29 |
| NFC-600 Automated Portable Retinal Camera (K210197) | Crystalvue Medical Corporation | 2021-04-13 |
| RetCam Envision (K203500) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021-04-13 |
| Fundus Camera (K202097) | Huvitz Co., Ltd. | 2021-02-02 |
| VX650 (K202221) | Luneau Technology Operations | 2021-01-29 |
| Optomed Smartscope M5 with Optomed Smartscope FA (K201325) | Optomed Oyj | 2020-11-20 |
| Canon non-mydriatic retinal camera CR series (K201122) | Canon, Inc. | 2020-07-23 |
| XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System (K193319) | Vasoptic Medical, Inc. | 2020-06-01 |
| Mydriatic Hyperspectral Retinal Camera (MHRC-C1) (K200254) | Optina Diagnostics | 2020-04-27 |
| Fundus Camera (K190954) | Chongqing Bio Newvision Medical Equipment , Ltd. | 2020-01-22 |
| KOWA nonmyd 8 (K191945) | Kowa Company , Ltd. | 2019-09-10 |
| KOWA DR-1a (K190573) | Kowa Company , Ltd. | 2019-06-04 |
| Microperimeter MP-3, Microperimeter MP-3 Type S (K190198) | Nidek Co., Ltd. | 2019-04-01 |
| NFC-700 non-mydriatic auto fundus camera (K182199) | Crystalvue Medical Corporation | 2019-01-02 |
| 3nethra neo (K183059) | Forus Health Pvt.Ltd | 2018-12-21 |
| LipiScan Dynamic Meibomian Imager (K182506) | Tearscience, Inc. | 2018-12-10 |
| RetCam 3 ; RetCam Shuttle ; RetCam Portable (K182263) | Natus Medical Incorporated | 2018-09-07 |
| RetiCapture (K173474) | Ilooda Co,., Ltd. | 2018-07-27 |
| Nexy (K180306) | Next Sight Srl | 2018-06-08 |
| Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module (K180378) | Optomed OY | 2018-04-05 |
| Phoenix Clinical ICON (K170527) | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017-09-15 |
| HAAG-STREIT FUNDUS MODULE 300 (K163021) | Optomed OY | 2017-04-11 |
| Eyenez Ophthalmic Camera (K161727) | Eyenez, LLC | 2016-10-04 |
| MICROPERIMETER MP-3 (K152729) | Nidek Co., Ltd. | 2016-06-06 |
| LSFG-NAVI (K153239) | Softcare Co., Ltd. | 2016-05-12 |
| LipiView II Ocular Surface Interferometer (K152869) | Tearscience, Inc. | 2016-01-14 |
| TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA (K141325) | Topcon Corp. | 2014-10-23 |
| TRC-NW400 NON-MYDRIATIC RETINAL CAMERA (K141481) | Topcon Corporation | 2014-09-17 |
| COBRA FUNDUS CAMERA (K132987) | C.S.O. S.R.L. | 2014-07-03 |
| KEELER KAPTURE SOFTWARE (K140450) | Keeler Limited | 2014-06-17 |
| OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 (K132186) | Optomed OY | 2013-12-18 |
| IFUSION (K130656) | Optovue, Inc. | 2013-07-03 |
| TRC-50DX RETINAL CAMERA (K123101) | Topcon Medical Systems, Inc. | 2013-06-05 |
| TRC-NW8 NON-MYDRIATIC RETINAL CAMERA (K130289) | Topcon Corp. | 2013-05-10 |
| DIGITAL RETINAL CAMERA (K123208) | Canon Inc. -Medical Equipment Group | 2013-03-19 |
| TRC-NW300 NON-MYDRIATIC RETINAL CAMERA (K123460) | Topcon Medical Systems, Inc. | 2013-02-06 |
| ICAM FUNDUS CAMERA (K122572) | Optovue, Inc. | 2013-01-11 |
| LIPIVIEW OCULAR SURFACE INTERFEROMETER (K122481) | Tearscience, Inc. | 2012-12-31 |
| PANOPTIC (K121405) | Welch Allyn, Inc. | 2012-12-20 |
| DIGITAL EYE-FUNDUS CAMERA (K120982) | Medimaging Integrated Solutions, Inc. (Miis) | 2012-09-28 |
| NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX (K113451) | Nidek Technologies Srl | 2012-05-08 |
| KOWA VX-20 (K112330) | Kowa Co. , Ltd. | 2012-02-16 |
| NON-CONTACT TEAR FILM THERMOGRAGH (K111771) | United Integrated Services Co., Ltd. | 2011-11-30 |
| DIGITAL RETINAL CAMERA (K111612) | Canon, Inc. | 2011-09-14 |
| VISTA DIGITAL OPTHALMOSCOPE (K102412) | Eyequick.Llc | 2011-06-23 |
| OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 (K110986) | Optomed OY | 2011-05-16 |
| RETCAM 3 OPTHALMIC IMAGING SYSTEM (K102859) | Clarity Medical Systems | 2011-04-20 |
| KOWA NONMYD WX (K101628) | Kowa Co. , Ltd. | 2011-01-26 |
| ISCREEN VISION SCREENER (K102651) | Iscreen Vision, Inc. | 2011-01-12 |
| TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM (K101861) | Truevision Systems, Incorporated | 2010-12-22 |
| FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 (K093071) | Fundus Photo, LLC | 2010-11-17 |
| DIGITAL RETINAL CAMERA (K102013) | Canon Inc. -Medical Equipment Group | 2010-10-29 |
| CENTERVUE DIGITAL RETINOGRAPHY SYSTEM (K101935) | Centervue S.P.A. | 2010-10-27 |
| DIGITAL RETINAL CAMERA CX-1 (K092565) | Canon Components, Inc. | 2010-03-18 |
| NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F (K100207) | Topcon Corp. | 2010-02-12 |
| RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS (K090326) | Clarity Medical Systems | 2009-11-25 |
| OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN (K092374) | Ophthalmic Imaging Systems | 2009-11-17 |
| LIPIVIEW OCULAR SURFACE INTERFEROMETER (K091935) | Tearscience, Inc. | 2009-10-23 |
| OPTOMED SMARTSCOPE, MODEL M3-1 EY1 (K092056) | Optomed OY | 2009-10-01 |
| KOWAGENESIS-DF (K091098) | Kowa Co. , Ltd. | 2009-08-07 |
| KOWA VX-10 A (K091683) | Kowa Co. , Ltd. | 2009-07-02 |
| RETINA CAMERA TRC-NW7SF MARK II (K090115) | Topcon Corp. | 2009-06-30 |
| STATIC VESSEL ANALYZER (K082196) | Imedos GmbH | 2009-06-16 |
| DIGITAL RETINAL CAMERA, CR-1 MARK II (K090466) | Canon, Inc. | 2009-03-23 |
| RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP (K083771) | Clarity Medical Systems | 2009-01-30 |
| MODIFICATION TO KOWA NONMYD ALPHA-DIII (K083387) | Kowa Co. , Ltd. | 2009-01-16 |
| RETCAM 3 OPHTHALMIC IMAGING SYSTEM (K081858) | Clarity Medical Systems | 2008-11-05 |
| KOWA NONMYD ALPHA-DIII (K082767) | Kowa Co. , Ltd. | 2008-10-21 |
| MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) (K080180) | Optical Imaging , Ltd. | 2008-06-11 |
| CR-1 (K080883) | Canon, Inc. | 2008-04-24 |
| KOWA GENESIS-D (K080681) | Kowa Co. , Ltd. | 2008-04-04 |
| ORION (K070231) | Nidek Technologies Srl | 2007-04-24 |
| CF-1 (K063717) | Canon, Inc. | 2007-01-23 |
| RETINAL FUNCTIONAL IMAGER (RFI) (K062416) | Optical Imaging , Ltd. | 2006-11-17 |
| KOWA VX-10I (K062021) | Kowa Co. , Ltd. | 2006-11-01 |
| IRI INTEGRATED RETINAL IMAGER (K062295) | Medivision Medical Imaging, Ltd. | 2006-10-20 |
| MP-1 MICROPERIMETER (K061768) | Nidek Technologies Srl | 2006-09-28 |
| KOWA NONMYD ALPHA-D (K062356) | Kowa Co. , Ltd. | 2006-09-27 |
| OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 (K053044) | Opto Global, Inc. | 2006-01-24 |
| KOWA NONMYD 7, KOWA NONMYD A-D (K053026) | Kowa Co. , Ltd. | 2005-11-10 |
| KOWA GENESIS-D HAND-HELD RETINAL CAMERA (K050271) | Kowa Co. , Ltd. | 2005-11-03 |
| VISUCAM PRO NM (K052268) | Carl Zeiss Meditec, AG | 2005-11-02 |
| KOWA VX-10 (K043213) | Kowa Co. , Ltd. | 2005-10-06 |
| VISCUCAM C DIGITAL CAMERA (K043222) | Carl Zeiss Meditec, AG | 2005-02-14 |
| TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA (K041367) | Topcon Corp. | 2004-11-05 |
| DIGITAL FUNDUS CAMERA, MODEL CF-60DSI (K041546) | Canon, Inc. | 2004-06-23 |