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Camera, Ophthalmic, Ac-Powered

FDA product code HKI · 153 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.1120
Review panel: OP
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-06-03 – 2026-06-22

HKI 2026-06-22

TearView

Applicant Beyond 700 Pty, Ltd.

K number K253176

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HKI 2026-01-16

Eyer 2

Applicant Phelcom Technologies

K number K251353

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HKI 2025-12-12

Fundus On Phone Non Mydriatic (FOP NM-10)

Applicant Remidio Innovative Solutions Private Limited

K number K252120

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HKI 2025-09-04

Optina-4C (MHRC-C1N)

Applicant Optina Diagnostics, Inc.

K number K250770

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HKI 2025-08-14

3nethra neo HD FA; 3nethra neo HD

Applicant Forus Health Pvt.Ltd

K number K243600

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HKI 2025-04-30

Resolve Fundus Camera

Applicant Optain Health, Inc.

K number K250683

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HKI 2024-12-17

Sentinel Camera

Applicant Ai Optics

K number K243664

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HKI 2024-12-09

Verily Numetric Retinal Camera

Applicant Verily Life Sciences, LLC

K number K242508

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HKI 2024-05-15

CANON Fundus Camera CR-10 (CR-10)

Applicant Canon, Inc.

K number K241049

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HKI 2023-12-05

Optina-4C (MHRC-C1N)

Applicant Optina Diagnostics, Inc.

K number K231230

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HKI 2023-11-20

Zilia Ocular FC (ZIL-10002)

Applicant Zilia, Inc.

K number K230627

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HKI 2023-09-06

Phoenix ICON, Phoenix ICON GO

Applicant Neolight, LLC

K number K223575

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HKI 2023-03-15

iExaminer System with Panoptic Plus

Applicant Welch Allyn, Inc.

K number K223381

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HKI 2023-02-22

Eyer Retinal Camera NM-STD

Applicant Phelcom Technologies

K number K221329

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HKI 2022-08-29

Non-Mydriatic Retinal Camera NW500

Applicant Topcon Corporation

K number K221111

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HKI 2021-04-13

NFC-600 Automated Portable Retinal Camera

Applicant Crystalvue Medical Corporation

K number K210197

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HKI 2021-04-13

RetCam Envision

Applicant Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)

K number K203500

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HKI 2021-02-02

Fundus Camera

Applicant Huvitz Co., Ltd.

K number K202097

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HKI 2021-01-29

VX650

Applicant Luneau Technology Operations

K number K202221

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HKI 2020-11-20

Optomed Smartscope M5 with Optomed Smartscope FA

Applicant Optomed Oyj

K number K201325

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HKI 2020-07-23

Canon non-mydriatic retinal camera CR series

Applicant Canon, Inc.

K number K201122

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HKI 2020-06-01

XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System

Applicant Vasoptic Medical, Inc.

K number K193319

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HKI 2020-04-27

Mydriatic Hyperspectral Retinal Camera (MHRC-C1)

Applicant Optina Diagnostics

K number K200254

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HKI 2020-01-22

Fundus Camera

Applicant Chongqing Bio Newvision Medical Equipment , Ltd.

K number K190954

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HKI 2019-09-10

KOWA nonmyd 8

Applicant Kowa Company , Ltd.

K number K191945

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HKI 2019-06-04

KOWA DR-1a

Applicant Kowa Company , Ltd.

K number K190573

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HKI 2019-04-01

Microperimeter MP-3, Microperimeter MP-3 Type S

Applicant Nidek Co., Ltd.

K number K190198

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HKI 2019-01-02

NFC-700 non-mydriatic auto fundus camera

Applicant Crystalvue Medical Corporation

K number K182199

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HKI 2018-12-21

3nethra neo

Applicant Forus Health Pvt.Ltd

K number K183059

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HKI 2018-12-10

LipiScan Dynamic Meibomian Imager

Applicant Tearscience, Inc.

K number K182506

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HKI 2018-09-07

RetCam 3 ; RetCam Shuttle ; RetCam Portable

Applicant Natus Medical Incorporated

K number K182263

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HKI 2018-07-27

RetiCapture

Applicant Ilooda Co,., Ltd.

K number K173474

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HKI 2018-06-08

Nexy

Applicant Next Sight Srl

K number K180306

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HKI 2018-04-05

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

Applicant Optomed OY

K number K180378

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HKI 2017-09-15

Phoenix Clinical ICON

Applicant Phoenix Technology Group, Inc. Dba Phoenix Clinical

K number K170527

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HKI 2017-04-11

HAAG-STREIT FUNDUS MODULE 300

Applicant Optomed OY

K number K163021

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HKI 2016-10-04

Eyenez Ophthalmic Camera

Applicant Eyenez, LLC

K number K161727

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HKI 2016-06-06

MICROPERIMETER MP-3

Applicant Nidek Co., Ltd.

K number K152729

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HKI 2016-05-12

LSFG-NAVI

Applicant Softcare Co., Ltd.

K number K153239

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HKI 2016-01-14

LipiView II Ocular Surface Interferometer

Applicant Tearscience, Inc.

K number K152869

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HKI 2013-12-18

OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2

Applicant Optomed OY

K number K132186

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HKI 2013-07-03

IFUSION

Applicant Optovue, Inc.

K number K130656

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HKI 2013-06-05

TRC-50DX RETINAL CAMERA

Applicant Topcon Medical Systems, Inc.

K number K123101

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HKI 2013-05-10

TRC-NW8 NON-MYDRIATIC RETINAL CAMERA

Applicant Topcon Corp.

K number K130289

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HKI 2013-03-19

DIGITAL RETINAL CAMERA

Applicant Canon Inc. -Medical Equipment Group

K number K123208

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HKI 2013-02-06

TRC-NW300 NON-MYDRIATIC RETINAL CAMERA

Applicant Topcon Medical Systems, Inc.

K number K123460

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HKI 2013-01-11

ICAM FUNDUS CAMERA

Applicant Optovue, Inc.

K number K122572

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HKI 2012-12-31

LIPIVIEW OCULAR SURFACE INTERFEROMETER

Applicant Tearscience, Inc.

K number K122481

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HKI 2012-12-20

PANOPTIC

Applicant Welch Allyn, Inc.

K number K121405

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HKI 2012-09-28

DIGITAL EYE-FUNDUS CAMERA

Applicant Medimaging Integrated Solutions, Inc. (Miis)

K number K120982

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HKI 2012-05-08

NON-MYDRIATIC AUTO FUNDUS CAMERA AFC-330 WITH IMAGE FILING SOFTWARE NA VIS-EX

Applicant Nidek Technologies Srl

K number K113451

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HKI 2012-02-16

KOWA VX-20

Applicant Kowa Co. , Ltd.

K number K112330

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HKI 2011-11-30

NON-CONTACT TEAR FILM THERMOGRAGH

Applicant United Integrated Services Co., Ltd.

K number K111771

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HKI 2011-09-14

DIGITAL RETINAL CAMERA

Applicant Canon, Inc.

K number K111612

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HKI 2011-06-23

VISTA DIGITAL OPTHALMOSCOPE

Applicant Eyequick.Llc

K number K102412

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HKI 2011-05-16

OPTOMED SMARTSCOPE M5 EY3 AND M5 ES1

Applicant Optomed OY

K number K110986

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HKI 2011-04-20

RETCAM 3 OPTHALMIC IMAGING SYSTEM

Applicant Clarity Medical Systems

K number K102859

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HKI 2011-01-26

KOWA NONMYD WX

Applicant Kowa Co. , Ltd.

K number K101628

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HKI 2011-01-12

ISCREEN VISION SCREENER

Applicant Iscreen Vision, Inc.

K number K102651

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HKI 2010-12-22

TRUEVISION 3D VISUALIZATION AND GUIDANCE SYSTEM

Applicant Truevision Systems, Incorporated

K number K101861

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HKI 2010-11-17

FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440

Applicant Fundus Photo, LLC

K number K093071

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HKI 2010-10-29

DIGITAL RETINAL CAMERA

Applicant Canon Inc. -Medical Equipment Group

K number K102013

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HKI 2010-10-27

CENTERVUE DIGITAL RETINOGRAPHY SYSTEM

Applicant Centervue S.P.A.

K number K101935

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HKI 2010-03-18

DIGITAL RETINAL CAMERA CX-1

Applicant Canon Components, Inc.

K number K092565

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HKI 2010-02-12

NON-MYDRIATIC RETINAL CAMERA, MODEL TRC-NW8F

Applicant Topcon Corp.

K number K100207

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HKI 2009-11-25

RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS

Applicant Clarity Medical Systems

K number K090326

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HKI 2009-11-17

OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN

Applicant Ophthalmic Imaging Systems

K number K092374

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HKI 2009-10-23

LIPIVIEW OCULAR SURFACE INTERFEROMETER

Applicant Tearscience, Inc.

K number K091935

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HKI 2009-10-01

OPTOMED SMARTSCOPE, MODEL M3-1 EY1

Applicant Optomed OY

K number K092056

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HKI 2009-08-07

KOWAGENESIS-DF

Applicant Kowa Co. , Ltd.

K number K091098

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HKI 2009-07-02

KOWA VX-10 A

Applicant Kowa Co. , Ltd.

K number K091683

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HKI 2009-06-30

RETINA CAMERA TRC-NW7SF MARK II

Applicant Topcon Corp.

K number K090115

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HKI 2009-06-16

STATIC VESSEL ANALYZER

Applicant Imedos GmbH

K number K082196

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HKI 2009-03-23

DIGITAL RETINAL CAMERA, CR-1 MARK II

Applicant Canon, Inc.

K number K090466

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HKI 2009-01-30

RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP

Applicant Clarity Medical Systems

K number K083771

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HKI 2009-01-16

MODIFICATION TO KOWA NONMYD ALPHA-DIII

Applicant Kowa Co. , Ltd.

K number K083387

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HKI 2008-11-05

RETCAM 3 OPHTHALMIC IMAGING SYSTEM

Applicant Clarity Medical Systems

K number K081858

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HKI 2008-10-21

KOWA NONMYD ALPHA-DIII

Applicant Kowa Co. , Ltd.

K number K082767

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HKI 2008-06-11

MODIFICATION TO RETINAL FUNCTION IMAGER (RFI)

Applicant Optical Imaging , Ltd.

K number K080180

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HKI 2008-04-24

CR-1

Applicant Canon, Inc.

K number K080883

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HKI 2008-04-04

KOWA GENESIS-D

Applicant Kowa Co. , Ltd.

K number K080681

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HKI 2007-04-24

ORION

Applicant Nidek Technologies Srl

K number K070231

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HKI 2007-01-23

CF-1

Applicant Canon, Inc.

K number K063717

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HKI 2006-11-17

RETINAL FUNCTIONAL IMAGER (RFI)

Applicant Optical Imaging , Ltd.

K number K062416

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HKI 2006-11-01

KOWA VX-10I

Applicant Kowa Co. , Ltd.

K number K062021

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HKI 2006-10-20

IRI INTEGRATED RETINAL IMAGER

Applicant Medivision Medical Imaging, Ltd.

K number K062295

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HKI 2006-09-28

MP-1 MICROPERIMETER

Applicant Nidek Technologies Srl

K number K061768

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HKI 2006-09-27

KOWA NONMYD ALPHA-D

Applicant Kowa Co. , Ltd.

K number K062356

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HKI 2006-01-24

OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5

Applicant Opto Global, Inc.

K number K053044

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HKI 2005-11-10

KOWA NONMYD 7, KOWA NONMYD A-D

Applicant Kowa Co. , Ltd.

K number K053026

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HKI 2005-11-03

KOWA GENESIS-D HAND-HELD RETINAL CAMERA

Applicant Kowa Co. , Ltd.

K number K050271

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HKI 2005-11-02

VISUCAM PRO NM

Applicant Carl Zeiss Meditec, AG

K number K052268

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HKI 2005-10-06

KOWA VX-10

Applicant Kowa Co. , Ltd.

K number K043213

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HKI 2005-02-14

VISCUCAM C DIGITAL CAMERA

Applicant Carl Zeiss Meditec, AG

K number K043222

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HKI 2004-11-05

TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA

Applicant Topcon Corp.

K number K041367

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HKI 2004-06-23

DIGITAL FUNDUS CAMERA, MODEL CF-60DSI

Applicant Canon, Inc.

K number K041546

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HKI 2004-03-08

PANORET, MODEL PNM 60

Applicant Medibell Medical Vision Technologies , Ltd.

K number K040325

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HKI 2003-06-06

CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI

Applicant Canon USA, Inc.

K number K031629

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HKI 2002-12-23

MP-1 MICRO PERIMETER

Applicant Nidek Technologies Srl

K number K023719

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HKI 2002-11-07

FUNDUS AUTOIMAGER

Applicant Visual Pathways, Inc.

K number K020888

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