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Ophthalmoscope, Ac-Powered

FDA product code HLI · 81 cleared devices

Class 2 Ophthalmic

Regulation: 21 CFR 886.1570
Review panel: OP
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-05-06 – 2016-02-11

HLI 2016-02-11

RTVue XR OCT Avanti with AngioVue Software

Applicant Optovue, Inc.

K number K153080

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HLI 2013-02-26

HEINE OMEGA 500

Applicant Heine Optotechnik GmbH & Co. KG

K number K123316

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HLI 2013-01-18

IVUE WITH NORMATIVE DATABASE

Applicant Optovue, Inc.

K number K121739

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HLI 2012-05-11

ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS)

Applicant Bioptigen, Inc.

K number K120057

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HLI 2012-04-03

RTVUE XR OCT

Applicant Optovue, Inc.

K number K120238

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HLI 2011-07-08

RHA2020

Applicant Annidis Health Systems Corp.

K number K111531

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HLI 2011-06-03

ISTAND

Applicant Optovue, Inc.

K number K103266

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HLI 2011-02-09

AAIO-7, AAIO WIRLESS

Applicant Appasamy Associates

K number K110205

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HLI 2010-09-15

RTVUE MODEL RTVUE 100

Applicant Optovue, Inc.

K number K101505

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HLI 2010-06-17

R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100

Applicant Optovue, Inc.

K number K100861

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HLI 2007-01-26

CIRRUS HD-OCT, MODEL 4000

Applicant Carl Zeiss Meditec, Inc.

K number K063378

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HLI 2006-12-13

BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM

Applicant Bioptigen, Inc.

K number K063343

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HLI 2006-08-23

RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER

Applicant Talia Technology , Ltd.

K number K061674

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HLI 2006-05-23

VANTAGE INDIRECT OPHTHALMOSCOPE

Applicant Keeler Instruments, Inc.

K number K060822

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HLI 2005-09-30

VISANTE OCT

Applicant Carl Zeiss Meditec, Inc.

K number K051789

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HLI 2005-01-21

OCT-OPTHALMOSCOPE

Applicant Ophthalmic Technologies, Inc.

K number K042885

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HLI 2004-10-07

PANORAMIC 200A

Applicant Optos Plc.

K number K042001

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HLI 2004-05-24

RTA MODEL D RETINAL THICKNESS ANALYZER

Applicant Talia Technology , Ltd.

K number K041290

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HLI 2004-04-20

STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE

Applicant Carl Zeiss Meditec, Inc.

K number K033123

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HLI 2003-05-06

RTA MODEL D RETINAL THICKNESS ANALYZER

Applicant Talia Technology , Ltd.

K number K031312

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HLI 2003-05-01

STRATUSOCT WITH RNFL NORMATIVE DATABASE

Applicant Carl Zeiss Meditec, Inc.

K number K030433

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HLI 2001-01-25

WELCH ALLYN 11800 OPTHALMOSCOPE

Applicant Welch Allyn, Inc.

K number K003376

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HLI 2000-09-20

CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ

Applicant Hai Laboratories, Inc.

K number K994340

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HLI 2000-06-21

CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100

Applicant Canon USA, Inc.

K number K992606

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HLI 2000-03-31

MODIFICATION TO RTA RETINAL THICKNESS ANALYZER

Applicant Talia Technology , Ltd.

K number K000731

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HLI 1999-02-03

PANORAMIC200 OPTHALMOSCOPE

Applicant Optos Plc.

K number K983999

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HLI 1998-08-05

S2LO

Applicant Odyssey Optical Systems, LLC

K number K981640

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HLI 1997-07-29

HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)

Applicant Heidelberg Engineering

K number K971671

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HLI 1997-03-19

SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE

Applicant Mira, Inc.

K number K951728

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HLI 1997-02-03

RTA RETINAL THICKNESS ANALYZER

Applicant Talia Technology , Ltd.

K number K964137

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HLI 1996-06-21

HUMPHREY OCT SCANNER

Applicant Carl Zeiss, Inc.

K number K961171

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HLI 1995-06-26

ANGIOSCAN (AS STAND ALONE INSTRUMENT)

Applicant Carl Zeiss Meditec, Inc.

K number K951132

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HLI 1995-06-06

WELCH ALLYN VIDEO OPHTHALMOSCOPE

Applicant Welch Allyn, Inc.

K number K951210

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HLI 1995-04-07

INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV

Applicant Neitz Instruments Company, Ltd.

K number K951338

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HLI 1995-04-04

WELCH ALLYN OPHTHALMOSCOPE

Applicant Welch Allyn, Inc.

K number K950461

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HLI 1994-11-14

RETINA ANGIOGRAPH

Applicant Heidelberg Engineering

K number K944261

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HLI 1994-11-14

RETINA TOMOGRAPH AND FLOWMETER

Applicant Heidelberg Engineering

K number K943956

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HLI 1994-11-14

RETINA FLOWMETER

Applicant Heidelberg Engineering

K number K943955

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HLI 1994-08-05

NEITZ HALOGEN OPHTHALMOSCOPE BXA-12

Applicant Neitz Instruments Company, Ltd.

K number K942720

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HLI 1994-08-05

NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC

Applicant Neitz Instruments Company, Ltd.

K number K942715

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HLI 1994-08-05

NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP

Applicant Neitz Instruments Company, Ltd.

K number K942714

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HLI 1994-08-05

NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H

Applicant Neitz Instruments Company, Ltd.

K number K942713

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HLI 1994-08-05

NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A

Applicant Neitz Instruments Company, Ltd.

K number K942712

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HLI 1994-08-05

NEITZ HALOGEN OPHTHALMOSCOPE BXA-123

Applicant Neitz Instruments Company, Ltd.

K number K942711

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HLI 1994-08-04

KEELER VANTAGE INDIRECT OPHTHALMOSCOPE

Applicant Keeler Instruments, Inc.

K number K942104

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HLI 1994-07-18

NERVE FIBER ANALYZER

Applicant Carl Zeiss Meditec, Inc.

K number K941705

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HLI 1994-02-22

R&D BATTERIES # 5615, 5234, 5097

Applicant R & D Batteries, Inc.

K number K935988

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HLI 1993-06-21

MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE

Applicant Welch Allyn, Inc.

K number K930023

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HLI 1993-03-26

TOPOGRAPHIC SCANNING SYSTEM TOPSS

Applicant Carl Zeiss Meditec, Inc.

K number K923742

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HLI 1992-10-27

REGALTECH MAXISCOPE

Applicant Regaltech Pty. , Ltd.

K number K921163

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HLI 1992-01-06

LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE

Applicant Hgm Medical Laser Systems, Inc.

K number K914484

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HLI 1991-12-23

ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)

Applicant Carl Zeiss, Inc.

K number K912581

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HLI 1991-10-23

PROFESSIONAL INDIRECT OPHTHALMOSCOPE

Applicant Clement Clarke, Inc.

K number K912397

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HLI 1991-10-09

GLAUCOMA-SCOPE

Applicant Ophthalmic Imaging Systems

K number K913118

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HLI 1991-09-27

HEIDELBERG RETINA TOMOGRAPH

Applicant Heidelberg Engineering

K number K912891

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HLI 1990-03-23

KEELER KONAN SPECULAR MICROSCOPE SP3300

Applicant Keeler Instruments, Inc.

K number K900111

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HLI 1989-09-11

MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE

Applicant Mentor O & O, Inc.

K number K895010

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HLI 1989-06-05

VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)

Applicant Keeler Instruments, Inc.

K number K893173

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HLI 1989-06-05

VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)

Applicant Keeler Instruments, Inc.

K number K893172

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HLI 1989-01-24

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE

Applicant Rodenstock Instrument Corp.

K number K882517

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HLI 1988-09-06

EOL, MODEL LIO

Applicant Eol, Inc.

K number K881984

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HLI 1987-06-10

RODENSTOCK SCANNING LASER OPHTHALMOSCOPE

Applicant G. Rodenstock Instrumente GmbH

K number K871268

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HLI 1985-11-12

THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE

Applicant Keeler Instruments, Inc.

K number K854244

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HLI 1985-05-01

AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS

Applicant American Medical Optics

K number K851264

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HLI 1985-05-01

AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP

Applicant American Medical Optics

K number K851263

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HLI 1985-04-30

AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA

Applicant American Medical Optics

K number K851262

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HLI 1985-02-15

MONOCULAR DIRECT OPHTHALMOSCOPE

Applicant Nidek, Inc.

K number K844971

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HLI 1985-02-15

NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE

Applicant Nidek, Inc.

K number K843597

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HLI 1985-02-15

NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE

Applicant Nidek, Inc.

K number K843596

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HLI 1984-12-19

CANON AUTO KERATOMETER K-1

Applicant Canon USA, Inc.

K number K844054

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HLI 1984-12-11

WOODLYN CLASSIC CATARACT ACUITY TEST

Applicant Woodlyn, Inc.

K number K843812

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HLI 1984-11-21

BINOCULAR INDIRECT OPHTHALMOSCOPE

Applicant Mentor O & O, Inc.

K number K843304

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HLI 1984-11-21

MAMIYA SLIT LAMP P-1

Applicant Okada Corp.

K number K843099

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HLI 1984-08-07

WOODLYN CLASSIC KERATOMETER

Applicant Woodlyn, Inc.

K number K841767

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HLI 1984-08-07

WOODLYN CLASSIC JAVAL OPHTHALMOMETER

Applicant Woodlyn, Inc.

K number K841764

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HLI 1984-08-07

WOODLYN CLASSIC SLIT LAMP HSSL-CL

Applicant Woodlyn, Inc.

K number K841761

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HLI 1984-08-02

WOODLYN SLIT LAMP HSSL-EC

Applicant Woodlyn, Inc.

K number K841763

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HLI 1982-08-10

ALCON INDIRECT OPHTHALMOSCOPE

Applicant Alcon Laboratories

K number K822104

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HLI 1979-12-11

BLUE FIELD ENTOPTOSCOPE BFE100

Applicant Medical Instrument Research Assoc., Inc.

K number K791510

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HLI 1977-12-13

OPHTHALMOSCOPE, BINOCULAR, INDIRECT

Applicant Varian Assoc., Inc.

K number K772214

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HLI 1977-05-06

OPHTHALMOSCOPE, MODEL #11100

Applicant Welch Allyn, Inc.

K number K770768

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