FDA Product Code
FDA Product Code HLI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Ophthalmic
- 21 CFR Citation
- 886.1570
510(k) Clearances — 87 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016-02-11 | Traditional | PDF ↗ |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2015-12-02 | Traditional | PDF ↗ |
| K142953 | OCT-Camera | Optomedical Technologies GmbH | 2015-03-04 | Traditional | PDF ↗ |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | 2014-09-17 | Abbreviated | PDF ↗ |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | 2014-04-23 | Traditional | PDF ↗ |
| K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Amico Diagnostic Incorporated | 2014-03-26 | Traditional | PDF ↗ |
| K133892 | IVUE 500 | Optovue, Inc. | 2014-03-19 | Traditional | PDF ↗ |
| K123316 | HEINE OMEGA 500 | Heine Optotechnik GmbH & Co. KG | 2013-02-26 | Abbreviated | PDF ↗ |
| K121739 | IVUE WITH NORMATIVE DATABASE | Optovue, Inc. | 2013-01-18 | Traditional | PDF ↗ |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | 2012-05-11 | Traditional | PDF ↗ |
| K120238 | RTVUE XR OCT | Optovue, Inc. | 2012-04-03 | Special | PDF ↗ |
| K111531 | RHA2020 | Annidis Health Systems Corp. | 2011-07-08 | Traditional | PDF ↗ |
| K103266 | ISTAND | Optovue, Inc. | 2011-06-03 | Traditional | PDF ↗ |
| K110205 | AAIO-7, AAIO WIRLESS | Appasamy Associates | 2011-02-09 | Traditional | PDF ↗ |
| K101505 | RTVUE MODEL RTVUE 100 | Optovue, Inc. | 2010-09-15 | Traditional | PDF ↗ |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Optovue, Inc. | 2010-06-17 | Special | PDF ↗ |
| K063378 | CIRRUS HD-OCT, MODEL 4000 | Carl Zeiss Meditec, Inc. | 2007-01-26 | Traditional | PDF ↗ |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Bioptigen, Inc. | 2006-12-13 | Traditional | PDF ↗ |
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2006-08-23 | Special | PDF ↗ |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 2006-05-23 | Special | PDF ↗ |
| K051789 | VISANTE OCT | Carl Zeiss Meditec, Inc. | 2005-09-30 | Traditional | PDF ↗ |
| K042885 | OCT-OPTHALMOSCOPE | Ophthalmic Technologies, Inc. | 2005-01-21 | Traditional | PDF ↗ |
| K042001 | PANORAMIC 200A | Optos Plc. | 2004-10-07 | Traditional | PDF ↗ |
| K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2004-05-24 | Special | PDF ↗ |
| K033123 | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2004-04-20 | Abbreviated | PDF ↗ |
| K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2003-05-06 | Special | PDF ↗ |
| K030433 | STRATUSOCT WITH RNFL NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2003-05-01 | Traditional | PDF ↗ |
| K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | Welch Allyn, Inc. | 2001-01-25 | Abbreviated | PDF ↗ |
| K994340 | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ | Hai Laboratories, Inc. | 2000-09-20 | Abbreviated | PDF ↗ |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Canon USA, Inc. | 2000-06-21 | Traditional | PDF ↗ |
| K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2000-03-31 | Special | PDF ↗ |
| K983999 | PANORAMIC200 OPTHALMOSCOPE | Optos Plc. | 1999-02-03 | Traditional | PDF ↗ |
| K981640 | S2LO | Odyssey Optical Systems, LLC | 1998-08-05 | Traditional | PDF ↗ |
| K971671 | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) | Heidelberg Engineering | 1997-07-29 | Traditional | PDF ↗ |
| K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | Mira, Inc. | 1997-03-19 | Traditional | PDF ↗ |
| K964137 | RTA RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 1997-02-03 | Traditional | PDF ↗ |
| K961171 | HUMPHREY OCT SCANNER | Carl Zeiss, Inc. | 1996-06-21 | Traditional | PDF ↗ |
| K951132 | ANGIOSCAN (AS STAND ALONE INSTRUMENT) | Carl Zeiss Meditec, Inc. | 1995-06-26 | Traditional | PDF ↗ |
| K951210 | WELCH ALLYN VIDEO OPHTHALMOSCOPE | Welch Allyn, Inc. | 1995-06-06 | Traditional | PDF ↗ |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | Neitz Instruments Company, Ltd. | 1995-04-07 | Traditional | PDF ↗ |
| K950461 | WELCH ALLYN OPHTHALMOSCOPE | Welch Allyn, Inc. | 1995-04-04 | Traditional | PDF ↗ |
| K944261 | RETINA ANGIOGRAPH | Heidelberg Engineering | 1994-11-14 | Traditional | PDF ↗ |
| K943956 | RETINA TOMOGRAPH AND FLOWMETER | Heidelberg Engineering | 1994-11-14 | Traditional | PDF ↗ |
| K943955 | RETINA FLOWMETER | Heidelberg Engineering | 1994-11-14 | Traditional | PDF ↗ |
| K942712 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942714 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942713 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942711 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942715 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942720 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 | Neitz Instruments Company, Ltd. | 1994-08-05 | Traditional | PDF ↗ |
| K942104 | KEELER VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1994-08-04 | Traditional | PDF ↗ |
| K941705 | NERVE FIBER ANALYZER | Carl Zeiss Meditec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K935988 | R&D BATTERIES # 5615, 5234, 5097 | R & D Batteries, Inc. | 1994-02-22 | Traditional | PDF ↗ |
| K930023 | MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE | Welch Allyn, Inc. | 1993-06-21 | Traditional | PDF ↗ |
| K923742 | TOPOGRAPHIC SCANNING SYSTEM TOPSS | Carl Zeiss Meditec, Inc. | 1993-03-26 | Traditional | PDF ↗ |
| K921163 | REGALTECH MAXISCOPE | Regaltech Pty. , Ltd. | 1992-10-27 | Traditional | PDF ↗ |
| K914484 | LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE | Hgm Medical Laser Systems, Inc. | 1992-01-06 | Traditional | PDF ↗ |
| K912581 | ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) | Carl Zeiss, Inc. | 1991-12-23 | Traditional | PDF ↗ |
| K912397 | PROFESSIONAL INDIRECT OPHTHALMOSCOPE | Clement Clarke, Inc. | 1991-10-23 | Traditional | PDF ↗ |
| K913118 | GLAUCOMA-SCOPE | Ophthalmic Imaging Systems | 1991-10-09 | Traditional | PDF ↗ |
| K912891 | HEIDELBERG RETINA TOMOGRAPH | Heidelberg Engineering | 1991-09-27 | Traditional | PDF ↗ |
| K900111 | KEELER KONAN SPECULAR MICROSCOPE SP3300 | Keeler Instruments, Inc. | 1990-03-23 | Traditional | PDF ↗ |
| K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE | Mentor O & O, Inc. | 1989-09-11 | Traditional | PDF ↗ |
| K893173 | VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) | Keeler Instruments, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K893172 | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) | Keeler Instruments, Inc. | 1989-06-05 | Traditional | PDF ↗ |
| K882517 | RODENSTOCK SCANNING LASER OPHTHALMOSCOPE | Rodenstock Instrument Corp. | 1989-01-24 | Traditional | PDF ↗ |
| K881984 | EOL, MODEL LIO | Eol, Inc. | 1988-09-06 | Traditional | PDF ↗ |
| K871268 | RODENSTOCK SCANNING LASER OPHTHALMOSCOPE | G. Rodenstock Instrumente GmbH | 1987-06-10 | Traditional | PDF ↗ |
| K854244 | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 1985-11-12 | Traditional | PDF ↗ |
| K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP | American Medical Optics | 1985-05-01 | Traditional | PDF ↗ |
| K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS | American Medical Optics | 1985-05-01 | Traditional | PDF ↗ |
| K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA | American Medical Optics | 1985-04-30 | Traditional | PDF ↗ |
| K843596 | NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE | Nidek, Inc. | 1985-02-15 | Traditional | PDF ↗ |
| K843597 | NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE | Nidek, Inc. | 1985-02-15 | Traditional | PDF ↗ |
| K844971 | MONOCULAR DIRECT OPHTHALMOSCOPE | Nidek, Inc. | 1985-02-15 | Traditional | PDF ↗ |
| K844054 | CANON AUTO KERATOMETER K-1 | Canon USA, Inc. | 1984-12-19 | Traditional | PDF ↗ |
| K843812 | WOODLYN CLASSIC CATARACT ACUITY TEST | Woodlyn, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K843099 | MAMIYA SLIT LAMP P-1 | Okada Corp. | 1984-11-21 | Traditional | PDF ↗ |
| K843304 | BINOCULAR INDIRECT OPHTHALMOSCOPE | Mentor O & O, Inc. | 1984-11-21 | Traditional | PDF ↗ |
| K841764 | WOODLYN CLASSIC JAVAL OPHTHALMOMETER | Woodlyn, Inc. | 1984-08-07 | Traditional | PDF ↗ |
| K841761 | WOODLYN CLASSIC SLIT LAMP HSSL-CL | Woodlyn, Inc. | 1984-08-07 | Traditional | PDF ↗ |
| K841767 | WOODLYN CLASSIC KERATOMETER | Woodlyn, Inc. | 1984-08-07 | Traditional | PDF ↗ |
| K841763 | WOODLYN SLIT LAMP HSSL-EC | Woodlyn, Inc. | 1984-08-02 | Traditional | PDF ↗ |
| K822104 | ALCON INDIRECT OPHTHALMOSCOPE | Alcon Laboratories | 1982-08-10 | Traditional | PDF ↗ |
| K791510 | BLUE FIELD ENTOPTOSCOPE BFE100 | Medical Instrument Research Assoc., Inc. | 1979-12-11 | Traditional | PDF ↗ |
| K772214 | OPHTHALMOSCOPE, BINOCULAR, INDIRECT | Varian Assoc., Inc. | 1977-12-13 | Traditional | PDF ↗ |
| K770768 | OPHTHALMOSCOPE, MODEL #11100 | Welch Allyn, Inc. | 1977-05-06 | Traditional | PDF ↗ |
Product code HLI · Class II · Ophthalmic. Data: openFDA.