FDA Product Code
FDA Product Code HKI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1120
510(k) Clearances — 157 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253176 | TearView | Beyond 700 Pty, Ltd. | 2026-06-22 | Traditional | PDF ↗ |
| K251353 | Eyer 2 | Phelcom Technologies | 2026-01-16 | Traditional | PDF ↗ |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | 2025-12-12 | Traditional | PDF ↗ |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2025-09-04 | Traditional | PDF ↗ |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | 2025-08-14 | Traditional | PDF ↗ |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | 2025-04-30 | Traditional | PDF ↗ |
| K243664 | Sentinel Camera | Ai Optics | 2024-12-17 | Traditional | PDF ↗ |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | 2024-12-09 | Traditional | PDF ↗ |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | 2024-05-15 | Special | PDF ↗ |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | 2023-12-05 | Special | PDF ↗ |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | 2023-11-20 | Traditional | PDF ↗ |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | 2023-09-06 | Traditional | PDF ↗ |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | 2023-03-15 | Traditional | PDF ↗ |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | 2023-02-22 | Traditional | PDF ↗ |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | 2022-08-29 | Traditional | PDF ↗ |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021-04-13 | Traditional | PDF ↗ |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | 2021-04-13 | Special | PDF ↗ |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | 2021-02-02 | Traditional | PDF ↗ |
| K202221 | VX650 | Luneau Technology Operations | 2021-01-29 | Traditional | PDF ↗ |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | 2020-11-20 | Traditional | PDF ↗ |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | 2020-07-23 | Special | PDF ↗ |
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | 2020-06-01 | Traditional | PDF ↗ |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | 2020-04-27 | Traditional | PDF ↗ |
| K190954 | Fundus Camera | Chongqing Bio Newvision Medical Equipment , Ltd. | 2020-01-22 | Traditional | PDF ↗ |
| K191945 | KOWA nonmyd 8 | Kowa Company , Ltd. | 2019-09-10 | Traditional | PDF ↗ |
| K190573 | KOWA DR-1a | Kowa Company , Ltd. | 2019-06-04 | Traditional | PDF ↗ |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Nidek Co., Ltd. | 2019-04-01 | Traditional | PDF ↗ |
| K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | 2019-01-02 | Traditional | PDF ↗ |
| K183059 | 3nethra neo | Forus Health Pvt.Ltd | 2018-12-21 | Traditional | PDF ↗ |
| K182506 | LipiScan Dynamic Meibomian Imager | Tearscience, Inc. | 2018-12-10 | Traditional | PDF ↗ |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated | 2018-09-07 | Special | PDF ↗ |
| K173474 | RetiCapture | Ilooda Co,., Ltd. | 2018-07-27 | Traditional | PDF ↗ |
| K180306 | Nexy | Next Sight Srl | 2018-06-08 | Traditional | PDF ↗ |
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed OY | 2018-04-05 | Traditional | PDF ↗ |
| K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | 2017-09-15 | Traditional | PDF ↗ |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | Optomed OY | 2017-04-11 | Traditional | PDF ↗ |
| K161727 | Eyenez Ophthalmic Camera | Eyenez, LLC | 2016-10-04 | Traditional | PDF ↗ |
| K152729 | MICROPERIMETER MP-3 | Nidek Co., Ltd. | 2016-06-06 | Traditional | PDF ↗ |
| K153239 | LSFG-NAVI | Softcare Co., Ltd. | 2016-05-12 | Traditional | PDF ↗ |
| K152869 | LipiView II Ocular Surface Interferometer | Tearscience, Inc. | 2016-01-14 | Traditional | PDF ↗ |
| K141325 | TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2014-10-23 | Traditional | PDF ↗ |
| K141481 | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA | Topcon Corporation | 2014-09-17 | Traditional | PDF ↗ |
| K132987 | COBRA FUNDUS CAMERA | C.S.O. S.R.L. | 2014-07-03 | Traditional | PDF ↗ |
| K140450 | KEELER KAPTURE SOFTWARE | Keeler Limited | 2014-06-17 | Traditional | PDF ↗ |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | Optomed OY | 2013-12-18 | Traditional | PDF ↗ |
| K130656 | IFUSION | Optovue, Inc. | 2013-07-03 | Special | PDF ↗ |
| K123101 | TRC-50DX RETINAL CAMERA | Topcon Medical Systems, Inc. | 2013-06-05 | Traditional | PDF ↗ |
| K130289 | TRC-NW8 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2013-05-10 | Special | PDF ↗ |
| K123208 | DIGITAL RETINAL CAMERA | Canon Inc. -Medical Equipment Group | 2013-03-19 | Traditional | PDF ↗ |
| K123460 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA | Topcon Medical Systems, Inc. | 2013-02-06 | Traditional | PDF ↗ |
| K122572 | ICAM FUNDUS CAMERA | Optovue, Inc. | 2013-01-11 | Traditional | PDF ↗ |
| K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | Tearscience, Inc. | 2012-12-31 | Traditional | PDF ↗ |
| K121405 | PANOPTIC | Welch Allyn, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K120982 | DIGITAL EYE-FUNDUS CAMERA | Medimaging Integrated Solutions, Inc. (Miis) | 2012-09-28 | Traditional | PDF ↗ |
| K113451 | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX | Nidek Technologies Srl | 2012-05-08 | Traditional | PDF ↗ |
| K112330 | KOWA VX-20 | Kowa Co. , Ltd. | 2012-02-16 | Traditional | PDF ↗ |
| K111771 | NON-CONTACT TEAR FILM THERMOGRAGH | United Integrated Services Co., Ltd. | 2011-11-30 | Traditional | PDF ↗ |
| K111612 | DIGITAL RETINAL CAMERA | Canon, Inc. | 2011-09-14 | Special | PDF ↗ |
| K102412 | VISTA DIGITAL OPTHALMOSCOPE | Eyequick.Llc | 2011-06-23 | Traditional | PDF ↗ |
| K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 | Optomed OY | 2011-05-16 | Traditional | PDF ↗ |
| K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM | Clarity Medical Systems | 2011-04-20 | Traditional | PDF ↗ |
| K101628 | KOWA NONMYD WX | Kowa Co. , Ltd. | 2011-01-26 | Traditional | PDF ↗ |
| K102651 | ISCREEN VISION SCREENER | Iscreen Vision, Inc. | 2011-01-12 | Special | PDF ↗ |
| K101861 | TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM | Truevision Systems, Incorporated | 2010-12-22 | Traditional | PDF ↗ |
| K093071 | FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 | Fundus Photo, LLC | 2010-11-17 | Traditional | PDF ↗ |
| K102013 | DIGITAL RETINAL CAMERA | Canon Inc. -Medical Equipment Group | 2010-10-29 | Special | PDF ↗ |
| K101935 | CENTERVUE DIGITAL RETINOGRAPHY SYSTEM | Centervue S.P.A. | 2010-10-27 | Traditional | PDF ↗ |
| K092565 | DIGITAL RETINAL CAMERA CX-1 | Canon Components, Inc. | 2010-03-18 | Traditional | PDF ↗ |
| K100207 | NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F | Topcon Corp. | 2010-02-12 | Traditional | PDF ↗ |
| K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | Clarity Medical Systems | 2009-11-25 | Traditional | PDF ↗ |
| K092374 | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN | Ophthalmic Imaging Systems | 2009-11-17 | Traditional | PDF ↗ |
| K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | Tearscience, Inc. | 2009-10-23 | Traditional | PDF ↗ |
| K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | Optomed OY | 2009-10-01 | Traditional | PDF ↗ |
| K091098 | KOWAGENESIS-DF | Kowa Co. , Ltd. | 2009-08-07 | Traditional | PDF ↗ |
| K091683 | KOWA VX-10 A | Kowa Co. , Ltd. | 2009-07-02 | Special | PDF ↗ |
| K090115 | RETINA CAMERA TRC-NW7SF MARK II | Topcon Corp. | 2009-06-30 | Traditional | PDF ↗ |
| K082196 | STATIC VESSEL ANALYZER | Imedos GmbH | 2009-06-16 | Traditional | PDF ↗ |
| K090466 | DIGITAL RETINAL CAMERA, CR-1 MARK II | Canon, Inc. | 2009-03-23 | Traditional | PDF ↗ |
| K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | Clarity Medical Systems | 2009-01-30 | Special | PDF ↗ |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | 2009-01-16 | Special | PDF ↗ |
| K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM | Clarity Medical Systems | 2008-11-05 | Traditional | PDF ↗ |
| K082767 | KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | 2008-10-21 | Special | PDF ↗ |
| K080180 | MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) | Optical Imaging , Ltd. | 2008-06-11 | Traditional | PDF ↗ |
| K080883 | CR-1 | Canon, Inc. | 2008-04-24 | Traditional | PDF ↗ |
| K080681 | KOWA GENESIS-D | Kowa Co. , Ltd. | 2008-04-04 | Special | PDF ↗ |
| K070231 | ORION | Nidek Technologies Srl | 2007-04-24 | Traditional | PDF ↗ |
| K063717 | CF-1 | Canon, Inc. | 2007-01-23 | Traditional | PDF ↗ |
| K062416 | RETINAL FUNCTIONAL IMAGER (RFI) | Optical Imaging , Ltd. | 2006-11-17 | Traditional | PDF ↗ |
| K062021 | KOWA VX-10I | Kowa Co. , Ltd. | 2006-11-01 | Traditional | PDF ↗ |
| K062295 | IRI INTEGRATED RETINAL IMAGER | Medivision Medical Imaging, Ltd. | 2006-10-20 | Traditional | PDF ↗ |
| K061768 | MP-1 MICROPERIMETER | Nidek Technologies Srl | 2006-09-28 | Traditional | PDF ↗ |
| K062356 | KOWA NONMYD ALPHA-D | Kowa Co. , Ltd. | 2006-09-27 | Special | PDF ↗ |
| K053044 | OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 | Opto Global, Inc. | 2006-01-24 | Traditional | PDF ↗ |
| K053026 | KOWA NONMYD 7, KOWA NONMYD A-D | Kowa Co. , Ltd. | 2005-11-10 | Traditional | PDF ↗ |
| K050271 | KOWA GENESIS-D HAND-HELD RETINAL CAMERA | Kowa Co. , Ltd. | 2005-11-03 | Traditional | PDF ↗ |
| K052268 | VISUCAM PRO NM | Carl Zeiss Meditec, AG | 2005-11-02 | Special | PDF ↗ |
| K043213 | KOWA VX-10 | Kowa Co. , Ltd. | 2005-10-06 | Traditional | PDF ↗ |
| K043222 | VISCUCAM C DIGITAL CAMERA | Carl Zeiss Meditec, AG | 2005-02-14 | Traditional | PDF ↗ |
| K041367 | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | 2004-11-05 | Traditional | PDF ↗ |
| K041546 | DIGITAL FUNDUS CAMERA, MODEL CF-60DSI | Canon, Inc. | 2004-06-23 | Traditional | PDF ↗ |
Product code HKI · Class II · Ophthalmic. Data: openFDA.