Product Code: HLI
FDA class 2
21 CFR 886.1570
Ophthalmoscope, Ac-Powered
Ophthalmic
The AC-Powered Ophthalmoscope is an electrically powered instrument used by clinicians to illuminate and examine the interior of the eye, including the retina, optic disc, macula, and blood vessels, for the diagnosis of ocular and systemic diseases. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification to demonstrate substantial equivalence to a predicate device. The product code is HLI, regulated under 21 CFR 886.1570, within the Ophthalmic medical specialty. No special risk flags apply to this device.
510(k)s
87
FEI Numbers
51
Registration Numbers
51
Unique Applicants
39
Years Active
39
Basic Information
- Product Code
- HLI
- Device Class
- FDA class 2
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 87 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Feb 11, 2016 | Substantially Equivalent | OPTOVUE, INC. |
| K150722 | EnFocus 2300, EnFocus 4400 | Dec 02, 2015 | Substantially Equivalent | BIOPTIGEN, INC. |
| K142953 | OCT-Camera | Mar 04, 2015 | Substantially Equivalent | OptoMedical Technologies GmbH |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Sep 17, 2014 | Substantially Equivalent | PROPPER MANUFACTURING CO.,INC. |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Apr 23, 2014 | Substantially Equivalent | CENTERVUE SPA |
| K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Mar 26, 2014 | Substantially Equivalent | AMICO DIAGNOSTIC INCORPORATED |
| K133892 | IVUE 500 | Mar 19, 2014 | Substantially Equivalent | OPTOVUE, INC. |
| K123316 | HEINE OMEGA 500 | Feb 26, 2013 | Substantially Equivalent | HEINE OPTOTECHNIK GMBH & CO. KG. |
| K121739 | IVUE WITH NORMATIVE DATABASE | Jan 18, 2013 | Substantially Equivalent | OPTOVUE, INC. |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | May 11, 2012 | Substantially Equivalent | BIOPTIGEN, INC. |
| K120238 | RTVUE XR OCT | Apr 03, 2012 | Substantially Equivalent | OPTOVUE, INC. |
| K111531 | RHA2020 | Jul 08, 2011 | Substantially Equivalent | ANNIDIS HEALTH SYSTEMS CORP. |
| K103266 | ISTAND | Jun 03, 2011 | Substantially Equivalent | OPTOVUE, INC. |
| K110205 | AAIO-7, AAIO WIRLESS | Feb 09, 2011 | Substantially Equivalent | APPASAMY ASSOCIATES |
| K101505 | RTVUE MODEL RTVUE 100 | Sep 15, 2010 | Substantially Equivalent | OPTOVUE, INC. |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Jun 17, 2010 | Substantially Equivalent | OPTOVUE, INC. |
| K063378 | CIRRUS HD-OCT, MODEL 4000 | Jan 26, 2007 | Substantially Equivalent | CARL ZEISS MEDITEC INC |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Dec 13, 2006 | Substantially Equivalent | BIOPTIGEN, INC. |
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Aug 23, 2006 | Substantially Equivalent | TALIA TECHNOLOGY LTD. |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | May 23, 2006 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K051789 | VISANTE OCT | Sep 30, 2005 | Substantially Equivalent | CARL ZEISS MEDITEC INC |
| K042885 | OCT-OPTHALMOSCOPE | Jan 21, 2005 | Substantially Equivalent | OPHTHALMIC TECHNOLOGIES, INC. |
| K042001 | PANORAMIC 200A | Oct 07, 2004 | Substantially Equivalent | OPTOS PLC |
| K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER | May 24, 2004 | Substantially Equivalent | TALIA TECHNOLOGY LTD. |
| K033123 | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE | Apr 20, 2004 | Substantially Equivalent | CARL ZEISS MEDITEC INC |
| K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER | May 06, 2003 | Substantially Equivalent | TALIA TECHNOLOGY LTD. |
| K030433 | STRATUSOCT WITH RNFL NORMATIVE DATABASE | May 01, 2003 | Substantially Equivalent | CARL ZEISS MEDITEC INC |
| K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | Jan 25, 2001 | Substantially Equivalent | WELCH ALLYN, INC. |
| K994340 | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ | Sep 20, 2000 | Substantially Equivalent | HAI LABORATORIES, INC. |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Jun 21, 2000 | Substantially Equivalent | CANON U.S.A., INC. |
| K000731 | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | Mar 31, 2000 | Substantially Equivalent | TALIA TECHNOLOGY LTD. |
| K983999 | PANORAMIC200 OPTHALMOSCOPE | Feb 03, 1999 | Substantially Equivalent | OPTOS PLC |
| K981640 | S2LO | Aug 05, 1998 | Substantially Equivalent | ODYSSEY OPTICAL SYSTEMS, LLC. |
| K971671 | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) | Jul 29, 1997 | Substantially Equivalent | HEIDELBERG ENGINEERING |
| K951728 | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | Mar 19, 1997 | Substantially Equivalent | MIRA, INC. |
| K964137 | RTA RETINAL THICKNESS ANALYZER | Feb 03, 1997 | Substantially Equivalent | TALIA TECHNOLOGY LTD. |
| K961171 | HUMPHREY OCT SCANNER | Jun 21, 1996 | Substantially Equivalent | CARL ZEISS, INC. |
| K951132 | ANGIOSCAN (AS STAND ALONE INSTRUMENT) | Jun 26, 1995 | Substantially Equivalent | CARLZEISS MEDITEC INC. |
| K951210 | WELCH ALLYN VIDEO OPHTHALMOSCOPE | Jun 06, 1995 | Substantially Equivalent | WELCH ALLYN, INC. |
| K951338 | INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV | Apr 07, 1995 | Substantially Equivalent | NEITZ INSTRUMENTS COMPANY, LTD. |
| K950461 | WELCH ALLYN OPHTHALMOSCOPE | Apr 04, 1995 | Substantially Equivalent | WELCH ALLYN, INC. |
| K944261 | RETINA ANGIOGRAPH | Nov 14, 1994 | Substantially Equivalent | HEIDELBERG ENGINEERING |
| K943956 | RETINA TOMOGRAPH AND FLOWMETER | Nov 14, 1994 | Substantially Equivalent | HEIDELBERG ENGINEERING |
| K943955 | RETINA FLOWMETER | Nov 14, 1994 | Substantially Equivalent | HEIDELBERG ENGINEERING |
| K942720 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-12 | Aug 05, 1994 | Substantially Equivalent | NEITZ INSTRUMENTS COMPANY, LTD. |
| K942715 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC | Aug 05, 1994 | Substantially Equivalent | NEITZ INSTRUMENTS COMPANY, LTD. |
| K942714 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP | Aug 05, 1994 | Substantially Equivalent | NEITZ INSTRUMENTS COMPANY, LTD. |
| K942713 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H | Aug 05, 1994 | Substantially Equivalent | NEITZ INSTRUMENTS COMPANY, LTD. |
| K942712 | NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A | Aug 05, 1994 | Substantially Equivalent | NEITZ INSTRUMENTS COMPANY, LTD. |
| K942711 | NEITZ HALOGEN OPHTHALMOSCOPE BXA-123 | Aug 05, 1994 | Substantially Equivalent | NEITZ INSTRUMENTS COMPANY, LTD. |
| K942104 | KEELER VANTAGE INDIRECT OPHTHALMOSCOPE | Aug 04, 1994 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K941705 | NERVE FIBER ANALYZER | Jul 18, 1994 | Substantially Equivalent | CARLZEISS MEDITEC INC. |
| K935988 | R&D BATTERIES # 5615, 5234, 5097 | Feb 22, 1994 | Substantially Equivalent | R & D BATTERIES, INC. |
| K930023 | MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE | Jun 21, 1993 | Substantially Equivalent | WELCH ALLYN, INC. |
| K923742 | TOPOGRAPHIC SCANNING SYSTEM TOPSS | Mar 26, 1993 | Substantially Equivalent | CARLZEISS MEDITEC INC. |
| K921163 | REGALTECH MAXISCOPE | Oct 27, 1992 | Substantially Equivalent | REGALTECH PTY. LTD. |
| K914484 | LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE | Jan 06, 1992 | Substantially Equivalent | HGM MEDICAL LASER SYSTEMS, INC. |
| K912581 | ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO) | Dec 23, 1991 | Substantially Equivalent | CARL ZEISS, INC. |
| K912397 | PROFESSIONAL INDIRECT OPHTHALMOSCOPE | Oct 23, 1991 | Substantially Equivalent | CLEMENT CLARKE, INC. |
| K913118 | GLAUCOMA-SCOPE | Oct 09, 1991 | Substantially Equivalent | OPHTHALMIC IMAGING SYSTEMS |
| K912891 | HEIDELBERG RETINA TOMOGRAPH | Sep 27, 1991 | Substantially Equivalent | HEIDELBERG ENGINEERING |
| K900111 | KEELER KONAN SPECULAR MICROSCOPE SP3300 | Mar 23, 1990 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE | Sep 11, 1989 | Substantially Equivalent | MENTOR O & O, INC. |
| K893173 | VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC) | Jun 05, 1989 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K893172 | VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED) | Jun 05, 1989 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K882517 | RODENSTOCK SCANNING LASER OPHTHALMOSCOPE | Jan 24, 1989 | Substantially Equivalent | RODENSTOCK INSTRUMENT CORP. |
| K881984 | EOL, MODEL LIO | Sep 06, 1988 | Substantially Equivalent | EOL, INC. |
| K871268 | RODENSTOCK SCANNING LASER OPHTHALMOSCOPE | Jun 10, 1987 | Substantially Equivalent | G. RODENSTOCK INSTRUMENTE GMBH |
| K854244 | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE | Nov 12, 1985 | Substantially Equivalent | KEELER INSTRUMENTS, INC. |
| K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS | May 01, 1985 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP | May 01, 1985 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA | Apr 30, 1985 | Substantially Equivalent | AMERICAN MEDICAL OPTICS |
| K844971 | MONOCULAR DIRECT OPHTHALMOSCOPE | Feb 15, 1985 | Substantially Equivalent | NIDEK, INC. |
| K843597 | NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE | Feb 15, 1985 | Substantially Equivalent | NIDEK, INC. |
| K843596 | NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE | Feb 15, 1985 | Substantially Equivalent | NIDEK, INC. |
| K844054 | CANON AUTO KERATOMETER K-1 | Dec 19, 1984 | Substantially Equivalent | CANON U.S.A., INC. |
| K843812 | WOODLYN CLASSIC CATARACT ACUITY TEST | Dec 11, 1984 | Substantially Equivalent | WOODLYN, INC. |
| K843304 | BINOCULAR INDIRECT OPHTHALMOSCOPE | Nov 21, 1984 | Substantially Equivalent | MENTOR O & O, INC. |
| K843099 | MAMIYA SLIT LAMP P-1 | Nov 21, 1984 | Substantially Equivalent | OKADA CORP. |
| K841767 | WOODLYN CLASSIC KERATOMETER | Aug 07, 1984 | Substantially Equivalent | WOODLYN, INC. |
| K841764 | WOODLYN CLASSIC JAVAL OPHTHALMOMETER | Aug 07, 1984 | Substantially Equivalent | WOODLYN, INC. |
| K841761 | WOODLYN CLASSIC SLIT LAMP HSSL-CL | Aug 07, 1984 | Substantially Equivalent | WOODLYN, INC. |
| K841763 | WOODLYN SLIT LAMP HSSL-EC | Aug 02, 1984 | Substantially Equivalent | WOODLYN, INC. |
| K822104 | ALCON INDIRECT OPHTHALMOSCOPE | Aug 10, 1982 | Substantially Equivalent | ALCON LABORATORIES |
| K791510 | BLUE FIELD ENTOPTOSCOPE BFE100 | Dec 11, 1979 | Substantially Equivalent | MEDICAL INSTRUMENT RESEARCH ASSOC., INC. |
| K772214 | OPHTHALMOSCOPE, BINOCULAR, INDIRECT | Dec 13, 1977 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K770768 | OPHTHALMOSCOPE, MODEL #11100 | May 06, 1977 | Substantially Equivalent | WELCH ALLYN, INC. |
FEI Numbers
This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.