HKI · Camera, Ophthalmic, Ac-Powered
Ophthalmic · 21 CFR 886.1120 · Class 2
Overview
| Product Code | HKI |
|---|---|
| Device Name | Camera, Ophthalmic, Ac-Powered |
| Regulation | 21 CFR 886.1120 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
Classification Rationale
Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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 a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Cleared Devices (156)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251353 | Eyer 2 | Phelcom Technologies | Jan 16, 2026 | SESE |
| K252120 | Fundus On Phone Non Mydriatic (FOP NM-10) | Remidio Innovative Solutions Private Limited | Dec 12, 2025 | SESE |
| K250770 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Sep 4, 2025 | SESE |
| K243600 | 3nethra neo HD FA; 3nethra neo HD | Forus Health Pvt.Ltd | Aug 14, 2025 | SESE |
| K250683 | Resolve Fundus Camera | Optain Health, Inc. | Apr 30, 2025 | SESE |
| K243664 | Sentinel Camera | Ai Optics | Dec 17, 2024 | SESE |
| K242508 | Verily Numetric Retinal Camera | Verily Life Sciences, LLC | Dec 9, 2024 | SESE |
| K241049 | CANON Fundus Camera CR-10 (CR-10) | Canon, Inc. | May 15, 2024 | SESE |
| K231230 | Optina-4C (MHRC-C1N) | Optina Diagnostics, Inc. | Dec 5, 2023 | SESE |
| K230627 | Zilia Ocular FC (ZIL-10002) | Zilia, Inc. | Nov 20, 2023 | SESE |
| K223575 | Phoenix ICON, Phoenix ICON GO | Neolight, LLC | Sep 6, 2023 | SESE |
| K223381 | iExaminer System with Panoptic Plus | Welch Allyn, Inc. | Mar 15, 2023 | SESE |
| K221329 | Eyer Retinal Camera NM-STD | Phelcom Technologies | Feb 22, 2023 | SESE |
| K221111 | Non-Mydriatic Retinal Camera NW500 | Topcon Corporation | Aug 29, 2022 | SESE |
| K210197 | NFC-600 Automated Portable Retinal Camera | Crystalvue Medical Corporation | Apr 13, 2021 | SESE |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | Apr 13, 2021 | SESE |
| K202097 | Fundus Camera | Huvitz Co., Ltd. | Feb 2, 2021 | SESE |
| K202221 | VX650 | Luneau Technology Operations | Jan 29, 2021 | SESE |
| K201325 | Optomed Smartscope M5 with Optomed Smartscope FA | Optomed Oyj | Nov 20, 2020 | SESE |
| K201122 | Canon non-mydriatic retinal camera CR series | Canon, Inc. | Jul 23, 2020 | SESE |
| K193319 | XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System | Vasoptic Medical, Inc. | Jun 1, 2020 | SESE |
| K200254 | Mydriatic Hyperspectral Retinal Camera (MHRC-C1) | Optina Diagnostics | Apr 27, 2020 | SESE |
| K190954 | Fundus Camera | Chongqing Bio Newvision Medical Equipment , Ltd. | Jan 22, 2020 | SESE |
| K191945 | KOWA nonmyd 8 | Kowa Company , Ltd. | Sep 10, 2019 | SESE |
| K190573 | KOWA DR-1a | Kowa Company , Ltd. | Jun 4, 2019 | SESE |
| K190198 | Microperimeter MP-3, Microperimeter MP-3 Type S | Nidek Co., Ltd. | Apr 1, 2019 | SESE |
| K182199 | NFC-700 non-mydriatic auto fundus camera | Crystalvue Medical Corporation | Jan 2, 2019 | SESE |
| K183059 | 3nethra neo | Forus Health Pvt.Ltd | Dec 21, 2018 | SESE |
| K182506 | LipiScan Dynamic Meibomian Imager | Tearscience, Inc. | Dec 10, 2018 | SESE |
| K182263 | RetCam 3 ; RetCam Shuttle ; RetCam Portable | Natus Medical Incorporated | Sep 7, 2018 | SESE |
| K173474 | RetiCapture | Ilooda Co,., Ltd. | Jul 27, 2018 | SESE |
| K180306 | Nexy | Next Sight Srl | Jun 8, 2018 | SESE |
| K180378 | Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module | Optomed OY | Apr 5, 2018 | SESE |
| K170527 | Phoenix Clinical ICON | Phoenix Technology Group, Inc. Dba Phoenix Clinical | Sep 15, 2017 | SESE |
| K163021 | HAAG-STREIT FUNDUS MODULE 300 | Optomed OY | Apr 11, 2017 | SESE |
| K161727 | Eyenez Ophthalmic Camera | Eyenez, LLC | Oct 4, 2016 | SESE |
| K152729 | MICROPERIMETER MP-3 | Nidek Co., Ltd. | Jun 6, 2016 | SESE |
| K153239 | LSFG-NAVI | Softcare Co., Ltd. | May 12, 2016 | SESE |
| K152869 | LipiView II Ocular Surface Interferometer | Tearscience, Inc. | Jan 14, 2016 | SESE |
| K141325 | TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | Oct 23, 2014 | SESE |
| K141481 | TRC-NW400 NON-MYDRIATIC RETINAL CAMERA | Topcon Corporation | Sep 17, 2014 | SESE |
| K132987 | COBRA FUNDUS CAMERA | C.S.O. S.R.L. | Jul 3, 2014 | SESE |
| K140450 | KEELER KAPTURE SOFTWARE | Keeler Limited | Jun 17, 2014 | SESE |
| K132186 | OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2 | Optomed OY | Dec 18, 2013 | SESE |
| K130656 | IFUSION | Optovue, Inc. | Jul 3, 2013 | SESE |
| K123101 | TRC-50DX RETINAL CAMERA | Topcon Medical Systems, Inc. | Jun 5, 2013 | SESE |
| K130289 | TRC-NW8 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | May 10, 2013 | SESE |
| K123208 | DIGITAL RETINAL CAMERA | Canon Inc. -Medical Equipment Group | Mar 19, 2013 | SESE |
| K123460 | TRC-NW300 NON-MYDRIATIC RETINAL CAMERA | Topcon Medical Systems, Inc. | Feb 6, 2013 | SESE |
| K122572 | ICAM FUNDUS CAMERA | Optovue, Inc. | Jan 11, 2013 | SESE |
| K122481 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | Tearscience, Inc. | Dec 31, 2012 | SESE |
| K121405 | PANOPTIC | Welch Allyn, Inc. | Dec 20, 2012 | SESE |
| K120982 | DIGITAL EYE-FUNDUS CAMERA | Medimaging Integrated Solutions, Inc. (Miis) | Sep 28, 2012 | SESE |
| K113451 | NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX | Nidek Technologies Srl | May 8, 2012 | SESE |
| K112330 | KOWA VX-20 | Kowa Co. , Ltd. | Feb 16, 2012 | SESE |
| K111771 | NON-CONTACT TEAR FILM THERMOGRAGH | United Integrated Services Co., Ltd. | Nov 30, 2011 | SESE |
| K111612 | DIGITAL RETINAL CAMERA | Canon, Inc. | Sep 14, 2011 | SESE |
| K102412 | VISTA DIGITAL OPTHALMOSCOPE | Eyequick.Llc | Jun 23, 2011 | SESE |
| K110986 | OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1 | Optomed OY | May 16, 2011 | SESE |
| K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM | Clarity Medical Systems | Apr 20, 2011 | SESE |
| K101628 | KOWA NONMYD WX | Kowa Co. , Ltd. | Jan 26, 2011 | SESE |
| K102651 | ISCREEN VISION SCREENER | Iscreen Vision, Inc. | Jan 12, 2011 | SESE |
| K101861 | TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM | Truevision Systems, Incorporated | Dec 22, 2010 | SESE |
| K093071 | FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 | Fundus Photo, LLC | Nov 17, 2010 | SESE |
| K102013 | DIGITAL RETINAL CAMERA | Canon Inc. -Medical Equipment Group | Oct 29, 2010 | SESE |
| K101935 | CENTERVUE DIGITAL RETINOGRAPHY SYSTEM | Centervue S.P.A. | Oct 27, 2010 | SESE |
| K092565 | DIGITAL RETINAL CAMERA CX-1 | Canon Components, Inc. | Mar 18, 2010 | SESE |
| K100207 | NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F | Topcon Corp. | Feb 12, 2010 | SESE |
| K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | Clarity Medical Systems | Nov 25, 2009 | SESE |
| K092374 | OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN | Ophthalmic Imaging Systems | Nov 17, 2009 | SESE |
| K091935 | LIPIVIEW OCULAR SURFACE INTERFEROMETER | Tearscience, Inc. | Oct 23, 2009 | SESE |
| K092056 | OPTOMED SMARTSCOPE, MODEL M3-1 EY1 | Optomed OY | Oct 1, 2009 | SESE |
| K091098 | KOWAGENESIS-DF | Kowa Co. , Ltd. | Aug 7, 2009 | SESE |
| K091683 | KOWA VX-10 A | Kowa Co. , Ltd. | Jul 2, 2009 | SESE |
| K090115 | RETINA CAMERA TRC-NW7SF MARK II | Topcon Corp. | Jun 30, 2009 | SESE |
| K082196 | STATIC VESSEL ANALYZER | Imedos GmbH | Jun 16, 2009 | SESE |
| K090466 | DIGITAL RETINAL CAMERA, CR-1 MARK II | Canon, Inc. | Mar 23, 2009 | SESE |
| K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | Clarity Medical Systems | Jan 30, 2009 | SESE |
| K083387 | MODIFICATION TO KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | Jan 16, 2009 | SESE |
| K081858 | RETCAM 3 OPHTHALMIC IMAGING SYSTEM | Clarity Medical Systems | Nov 5, 2008 | SESE |
| K082767 | KOWA NONMYD ALPHA-DIII | Kowa Co. , Ltd. | Oct 21, 2008 | SESE |
| K080180 | MODIFICATION TO RETINAL FUNCTION IMAGER (RFI) | Optical Imaging , Ltd. | Jun 11, 2008 | SESE |
| K080883 | CR-1 | Canon, Inc. | Apr 24, 2008 | SESE |
| K080681 | KOWA GENESIS-D | Kowa Co. , Ltd. | Apr 4, 2008 | SESE |
| K070231 | ORION | Nidek Technologies Srl | Apr 24, 2007 | SESE |
| K063717 | CF-1 | Canon, Inc. | Jan 23, 2007 | SESE |
| K062416 | RETINAL FUNCTIONAL IMAGER (RFI) | Optical Imaging , Ltd. | Nov 17, 2006 | SESE |
| K062021 | KOWA VX-10I | Kowa Co. , Ltd. | Nov 1, 2006 | SESE |
| K062295 | IRI INTEGRATED RETINAL IMAGER | Medivision Medical Imaging, Ltd. | Oct 20, 2006 | SESE |
| K061768 | MP-1 MICROPERIMETER | Nidek Technologies Srl | Sep 28, 2006 | SESE |
| K062356 | KOWA NONMYD ALPHA-D | Kowa Co. , Ltd. | Sep 27, 2006 | SESE |
| K053044 | OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 | Opto Global, Inc. | Jan 24, 2006 | SESE |
| K053026 | KOWA NONMYD 7, KOWA NONMYD A-D | Kowa Co. , Ltd. | Nov 10, 2005 | SESE |
| K050271 | KOWA GENESIS-D HAND-HELD RETINAL CAMERA | Kowa Co. , Ltd. | Nov 3, 2005 | SESE |
| K052268 | VISUCAM PRO NM | Carl Zeiss Meditec, AG | Nov 2, 2005 | SESE |
| K043213 | KOWA VX-10 | Kowa Co. , Ltd. | Oct 6, 2005 | SESE |
| K043222 | VISCUCAM C DIGITAL CAMERA | Carl Zeiss Meditec, AG | Feb 14, 2005 | SESE |
| K041367 | TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA | Topcon Corp. | Nov 5, 2004 | SESE |
| K041546 | DIGITAL FUNDUS CAMERA, MODEL CF-60DSI | Canon, Inc. | Jun 23, 2004 | SESE |
| K040325 | PANORET, MODEL PNM 60 | Medibell Medical Vision Technologies , Ltd. | Mar 8, 2004 | SESE |
| K031629 | CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI | Canon USA, Inc. | Jun 6, 2003 | SESE |
| K023719 | MP-1 MICRO PERIMETER | Nidek Technologies Srl | Dec 23, 2002 | SESE |
| K020888 | FUNDUS AUTOIMAGER | Visual Pathways, Inc. | Nov 7, 2002 | SESE |
| K022164 | ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM | Zeta Development Laboratories | Jul 26, 2002 | SESE |
| K014274 | NON-MYDRIATIC FUNDUS CAMERA, MODEL NM-1000 | Nidek, Inc. | Apr 17, 2002 | SESE |
| K011877 | FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM | Carl Zeiss Jena GmbH | Sep 26, 2001 | SESE |
| K010315 | ISCREEN VISION SCREENER | Iscreen, LLC | Jun 1, 2001 | SESE |
| K002920 | MEGAVISION CPX, MEGAVISION FA, MODEL I AND II | Escalon Medical Corp. | Dec 18, 2000 | SESE |
| K003236 | RETINADX | Regulatory Associates, Inc. | Nov 2, 2000 | SESE |
| K001275 | RETCAM II | Massie Research Laboratories, Inc. | Jul 13, 2000 | SESE |
| K000368 | EYECAP IMAGING SYSTEM | Clement Clarke Intl., Ltd. | May 4, 2000 | SESE |
| K990205 | DIGISCOPE OPHTHALMIC CAMERA | Eye Tel Imaging, Inc. | Mar 26, 1999 | SESE |
| K982689 | WINSTATION RETINAL IMAGER | Ophthalmic Imaging Systems | Oct 23, 1998 | SESE |
| K974535 | DISCAM DIGITAL IMAGING SYSTEM | Marcher Enterprises, Ltd. | Aug 14, 1998 | SESE |
| K980295 | OPHTHAVISION IMAGING SYSTEM | Mrp Group, Inc. | May 19, 1998 | SESE |
| K980246 | NON-MYDRIATIC RETINAL CAMERA, MODEL CR6-45NM | Canon USA, Inc. | May 6, 1998 | SESE |
| K980357 | KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER | Konan, Inc. | Apr 24, 1998 | SESE |
| K973950 | RETINAL CUBE | Applied Spectral Imaging , Ltd. | Dec 12, 1997 | SESE |
| K973533 | NIDEK STEREO DISC CAMERA(3-DX)/NIDEK STEREO FUNDUS CAMERA(3-DXF) | Nidek, Inc. | Nov 4, 1997 | SESE |
| K973218 | NIDEK HANDY | Nidek, Inc. | Nov 4, 1997 | SESE |
| K972440 | CATARACTSCREENER CT - S | Neitz Instruments Company, Ltd. | Sep 30, 1997 | SESE |
| K971685 | IMAGESCAPE DIGITAL RETINAL IMAGE SYSTEM | Tomey Corporation USA | Jun 24, 1997 | SESE |
| K963333 | OPTRONICS EPIC COLOR TELEVISION CAMERA SYSTEM (S97340) | Karl Storz Imaging, Inc. | Oct 22, 1996 | SESE |
| K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | Kowa Optimed, Inc. | Jan 3, 1996 | SESE |
| K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA | Kowa Optimed, Inc. | Dec 1, 1995 | SESE |
| K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C | Kowa Optimed, Inc. | Dec 1, 1995 | SESE |
| K953973 | ANGIOVISION 1000 | Medivision Medical Imaging, Ltd. | Nov 17, 1995 | SESE |
| K953972 | ANGIOVISION VIEWING STATION | Medivision Medical Imaging, Ltd. | Nov 17, 1995 | SESE |
| K952480 | ORIMS DIGITAL ANGIOGRAPHY SYSTEM | Midwest Ophthalmic Instruments, Inc. | Aug 25, 1995 | SESE |
| K941234 | NON-MYDRIATIC RETINAL CAMERA | Canon USA, Inc. | Jun 7, 1995 | SESE |
| K950091 | KONAN NONCON ROBO SPECULAR MICROSCOPE, MODELS SP 6000 AND SP 8000 | Konan Medical, Inc. | Mar 1, 1995 | SESE |
| K946058 | 60 FUNDUS CAMERA CF-60UV | Canon USA, Inc. | Feb 3, 1995 | SESE |
| K934663 | 60 DEGREE FUNDUS CAMERA, CF-60UD | Canon USA, Inc. | Feb 22, 1994 | SESE |
| K930442 | MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS | Marco Ophthalmic, Inc. | Aug 9, 1993 | SESE |
| K923708 | LEMPERT OPTIC DISC ANALYSIS SYSTEM | Lempert Ophthalmic Instruments | Mar 19, 1993 | SESE |
| K923958 | CHROMOS IMAGER | Chromos Imaging, Inc. | Mar 4, 1993 | SESE |
| K913314 | CANDELA RETINAL CAMERA | Candela Laser Corp. | Jan 23, 1992 | SESE |
| K913929 | DFC-1024 & DFC-512 DIGITAL IMAGING SYSTEM | Ophthalmic Imaging Systems | Nov 27, 1991 | SESE |
| K911439 | NON-MYDRIATIC RETINAL CAMERA, CR-45UAF | Canon USA, Inc. | Jun 17, 1991 | SESE |
| K895474 | NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL | Canon USA, Inc. | Oct 4, 1989 | SESE |
| K884989 | NEVISCAN MODEL N - 100 | Special Products, Inc. | Feb 28, 1989 | SESE |
| K874355 | OPACITY LENSMETER 701 | Intraoptics, Inc. | Jan 26, 1988 | SESE |
| K874017 | MODIFIED RETINAL CAMERA MODEL CR4-45NM | Canon USA, Inc. | Nov 2, 1987 | SESE |
| K873157 | OXFORD RETRO-ILLUMINATION CATARACT CAMERA | Holofax , Ltd. | Sep 30, 1987 | SESE |
| K862323 | CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM | Canon USA, Inc. | Aug 21, 1986 | SESE |
| K855170 | CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM | Canon USA, Inc. | Feb 27, 1986 | SESE |
| K854330 | IS-2000 DIGITAL OPHTHALMIC IMAGING SYSTEM | Par Technology Park | Dec 13, 1985 | SESE |
| K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 | Zeiss Humphrey System | Aug 12, 1985 | SESE |
| K843899 | GRC-WT, GRC-W | Olympus Corp. | Jan 28, 1985 | SESE |
| K844898 | CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM | Canon USA, Inc. | Jan 22, 1985 | SESE |
| K843021 | CANON 60 FUNDUS CAMERA CF-60U | Canon USA, Inc. | Oct 5, 1984 | SESE |
| K833694 | TEXAS BIO SCAN | Texas Bio Scan | Mar 2, 1984 | SESE |
| K822991 | AO DOCUSTAR(MMIRO) FUNDUS CAMERA | Warner-Lambert Co. | Feb 24, 1983 | SESE |
| K823719 | AML (ANGLE MAGNIFYING LENS | Nikon, Inc. | Jan 5, 1983 | SESE |
| K822908 | COHERENT FUNDUSL RETINAL CAMERA | Coherent Medical Division | Jan 5, 1983 | SESE |
| K770888 | POMERANTZEFF EQUATOR PLUS CAMERA | Medical Instrument Research Assoc., Inc. | Jun 3, 1977 | SESE |
Top Applicants
- Kowa Co. , Ltd. — 12 clearances
- Canon USA, Inc. — 12 clearances
- Canon, Inc. — 7 clearances
- Topcon Corp. — 5 clearances
- Optomed OY — 5 clearances
