Ophthalmoscope, Ac-Powered
FDA product code HLI · Class II (moderate risk) · 21 CFR 886.1570 · Ophthalmic
87510(k) clearances
0PMA approvals
7recalls
Manufacturers
- Carl Zeiss Meditec, AG 7
- Neitz Instruments Company, Ltd. 7
- Optovue, Inc. 7
- Keeler Instruments, Inc. 6
- Welch Allyn, Inc. 5
- Woodlyn, Inc. 5
- Talia Technology , Ltd. 5
- Heidelberg Engineering GmbH 5
- Nidek, Inc. 3
- American Medical Optics 3
- Bioptigen, Inc. 3
- Mentor O & O, Inc. 2
- Canon USA, Inc. 2
- Optos Plc. 2
- Carl Zeiss, Inc. 2
- Eol, Inc. 1
- Varian Assoc., Inc. 1
- Optomedical Technologies GmbH 1
- Alcon Laboratories 1
- G. Rodenstock Instrumente GmbH 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue SoftwareHLI · Traditional | Optovue, Inc. | 02/11/2016SE |
| K150722 | EnFocus 2300, EnFocus 4400HLI · Traditional | Bioptigen, Inc. | 12/02/2015SE |
| K142953 | OCT-CameraHLI · Traditional | Optomedical Technologies GmbH | 03/04/2015SE |
| K141638 | Propper Insight Binocular Indirect OphthalmosopeHLI · Abbreviated | Propper Manufacturing Co., Inc. | 09/17/2014SE |
| K133758 | Centervue Macular Integrity AssessmentHLI · Traditional | Centervue S.P.A. | 04/23/2014SE |
| K131939 | Amico DH-W35 Ophthalmoscope SeriesHLI · Traditional | Amico Diagnostic Incorporated | 03/26/2014SE |
| K133892 | Ivue 500HLI · Traditional | Optovue, Inc. | 03/19/2014SE |
| K123316 | Heine Omega 500HLI · Abbreviated | Heine Optotechnik GmbH & Co. KG | 02/26/2013SE |
| K121739 | Ivue with Normative DatabaseHLI · Traditional | Optovue, Inc. | 01/18/2013SE |
| K120057 | Envisu Spectral Domain Ophthalmic Imaging System (Sdois)HLI · Traditional | Bioptigen, Inc. | 05/11/2012SE |
| K120238 | Rtvue XR OctHLI · Special | Optovue, Inc. | 04/03/2012SE |
| K111531 | RHA2020HLI · Traditional | Annidis Health Systems Corp. | 07/08/2011SE |
| K103266 | IstandHLI · Traditional | Optovue, Inc. | 06/03/2011SE |
| K110205 | AAIO-7, Aaio WirlessHLI · Traditional | Appasamy Associates | 02/09/2011SE |
| K101505 | Rtvue Model Rtvue 100HLI · Traditional | Optovue, Inc. | 09/15/2010SE |
| K100861 | R T Vue with Software 5.0 Model: R I Vue 100HLI · Special | Optovue, Inc. | 06/17/2010SE |
| K063378 | Cirrus Hd-Oct, Model 4000HLI · Traditional | Carl Zeiss Meditec, Inc. | 01/26/2007SE |
| K063343 | Bioptigen Spectral Domain Ophthalmic Imaging SystemHLI · Traditional | Bioptigen, Inc. | 12/13/2006SE |
| K061674 | Rta 5 & Rta Model E Retinal Thickness AnalyzerHLI · Special | Talia Technology , Ltd. | 08/23/2006SE |
| K060822 | Vantage Indirect OphthalmoscopeHLI · Special | Keeler Instruments, Inc. | 05/23/2006SE |
| K051789 | Visante OctHLI · Traditional | Carl Zeiss Meditec, Inc. | 09/30/2005SE |
| K042885 | Oct-OpthalmoscopeHLI · Traditional | Ophthalmic Technologies, Inc. | 01/21/2005SE |
| K042001 | Panoramic 200AHLI · Traditional | Optos Plc. | 10/07/2004SE |
| K041290 | Rta Model D Retinal Thickness AnalyzerHLI · Special | Talia Technology , Ltd. | 05/24/2004SE |
| K033123 | Stratusoct with RNFL & Macula Normative DatabaseHLI · Abbreviated | Carl Zeiss Meditec, Inc. | 04/20/2004SE |
| K031312 | Rta Model D Retinal Thickness AnalyzerHLI · Special | Talia Technology , Ltd. | 05/06/2003SE |
| K030433 | Stratusoct with RNFL Normative DatabaseHLI · Traditional | Carl Zeiss Meditec, Inc. | 05/01/2003SE |
| K003376 | Welch Allyn 11800 OpthalmoscopeHLI · Abbreviated | Welch Allyn, Inc. | 01/25/2001SE |
| K994340 | Clinical Specular Microscope, Model Hai CL-1000XYZHLI · Abbreviated | Hai Laboratories, Inc. | 09/20/2000SE |
| K992606 | Canon Laser Blood Flowmeter (CLBF) Model 100HLI · Traditional | Canon USA, Inc. | 06/21/2000SE |
| K000731 | Modification to Rta Retinal Thickness AnalyzerHLI · Special | Talia Technology , Ltd. | 03/31/2000SE |
| K983999 | PANORAMIC200 OpthalmoscopeHLI · Traditional | Optos Plc. | 02/03/1999SE |
| K981640 | S2LOHLI · Traditional | Odyssey Optical Systems, LLC | 08/05/1998SE |
| K971671 | Heidelberg Retina Angiograph Fa/Icga (Hra/C)HLI · Traditional | Heidelberg Engineering | 07/29/1997SE |
| K951728 | Schepens-Yoshida Video Binocular Indirect OphthalmscopeHLI · Traditional | Mira, Inc. | 03/19/1997SE |
| K964137 | Rta Retinal Thickness AnalyzerHLI · Traditional | Talia Technology , Ltd. | 02/03/1997SE |
| K961171 | Humphrey Oct ScannerHLI · Traditional | Carl Zeiss, Inc. | 06/21/1996SE |
| K951132 | Angioscan (AS Stand Alone Instrument)HLI · Traditional | Carl Zeiss Meditec, Inc. | 06/26/1995SE |
| K951210 | Welch Allyn Video OphthalmoscopeHLI · Traditional | Welch Allyn, Inc. | 06/06/1995SE |
| K951338 | Indirect Ophthalmoscope Video System IO0 a TVHLI · Traditional | Neitz Instruments Company, Ltd. | 04/07/1995SE |
| K950461 | Welch Allyn OphthalmoscopeHLI · Traditional | Welch Allyn, Inc. | 04/04/1995SE |
| K944261 | Retina AngiographHLI · Traditional | Heidelberg Engineering | 11/14/1994SE |
| K943956 | Retina Tomograph and FlowmeterHLI · Traditional | Heidelberg Engineering | 11/14/1994SE |
| K943955 | Retina FlowmeterHLI · Traditional | Heidelberg Engineering | 11/14/1994SE |
| K942720 | Neitz Halogen Ophthalmoscope BXA-12HLI · Traditional | Neitz Instruments Company, Ltd. | 08/05/1994SE |
| K942715 | Neitz Halogen Ophthalmoscope Bxa-RcHLI · Traditional | Neitz Instruments Company, Ltd. | 08/05/1994SE |
| K942714 | Neitz Halogen Ophthalmoscope Bxa-RpHLI · Traditional | Neitz Instruments Company, Ltd. | 08/05/1994SE |
| K942713 | Neitz Halogen Binocular Indirect Ophthalmoscope Io-HHLI · Traditional | Neitz Instruments Company, Ltd. | 08/05/1994SE |
| K942712 | Neitz Halogen Binocular Indirect Ophthalmoscope Io-AHLI · Traditional | Neitz Instruments Company, Ltd. | 08/05/1994SE |
| K942711 | Neitz Halogen Ophthalmoscope BXA-123HLI · Traditional | Neitz Instruments Company, Ltd. | 08/05/1994SE |
| K942104 | Keeler Vantage Indirect OphthalmoscopeHLI · Traditional | Keeler Instruments, Inc. | 08/04/1994SE |
| K941705 | Nerve Fiber AnalyzerHLI · Traditional | Carl Zeiss Meditec, Inc. | 07/18/1994SE |
| K935988 | R&D Batteries # 5615, 5234, 5097HLI · Traditional | R & D Batteries, Inc. | 02/22/1994SE |
| K930023 | Model #12000 Binocular Inderect OphthalmoscopeHLI · Traditional | Welch Allyn, Inc. | 06/21/1993SE |
| K923742 | Topographic Scanning System TopssHLI · Traditional | Carl Zeiss Meditec, Inc. | 03/26/1993SE |
| K921163 | Regaltech MaxiscopeHLI · Traditional | Regaltech Pty. , Ltd. | 10/27/1992SE |
| K914484 | Litespot(Tm) Laser Indirect OphthalmoscopeHLI · Traditional | Hgm Medical Laser Systems, Inc. | 01/06/1992SE |
| K912581 | Zeiss Confocal Laser Scanning Ophthalmoscope(Clso)HLI · Traditional | Carl Zeiss, Inc. | 12/23/1991SE |
| K912397 | Professional Indirect OphthalmoscopeHLI · Traditional | Clement Clarke, Inc. | 10/23/1991SE |
| K913118 | Glaucoma-ScopeHLI · Traditional | Ophthalmic Imaging Systems | 10/09/1991SE |
| K912891 | Heidelberg Retina TomographHLI · Traditional | Heidelberg Engineering | 09/27/1991SE |
| K900111 | Keeler Konan Specular Microscope SP3300HLI · Traditional | Keeler Instruments, Inc. | 03/23/1990SE |
| K895010 | Mentor Spectacle Binocular Indirect OphthalmoscopeHLI · Traditional | Mentor O & O, Inc. | 09/11/1989SE |
| K893173 | Vista Specialist Ophthalmoscope (Battery & Ac)HLI · Traditional | Keeler Instruments, Inc. | 06/05/1989SE |
| K893172 | Vista Ophthalmoscope (Battery and Ac-Powered)HLI · Traditional | Keeler Instruments, Inc. | 06/05/1989SE |
| K882517 | Rodenstock Scanning Laser OphthalmoscopeHLI · Traditional | Rodenstock Instrument Corp. | 01/24/1989SE |
| K881984 | Eol, Model LioHLI · Traditional | Eol, Inc. | 09/06/1988SE |
| K871268 | Rodenstock Scanning Laser OphthalmoscopeHLI · Traditional | G. Rodenstock Instrumente GmbH | 06/10/1987SE |
| K854244 | The Keeler All Pupil Indirect OphthalmoscopeHLI · Traditional | Keeler Instruments, Inc. | 11/12/1985SE |
| K851264 | Amer. Medical Optics Monocular Indirect OphthalmasHLI · Traditional | American Medical Optics | 05/01/1985SE |
| K851263 | Amer. Medical Optic Monocular Direct OphthalmascopHLI · Traditional | American Medical Optics | 05/01/1985SE |
| K851262 | Amer. Medical Optical Binocular Indirect OphthalmaHLI · Traditional | American Medical Optics | 04/30/1985SE |
| K844971 | Monocular Direct OphthalmoscopeHLI · Traditional | Nidek, Inc. | 02/15/1985SE |
| K843597 | Nidek Monocular Indirect OphthalmoscopeHLI · Traditional | Nidek, Inc. | 02/15/1985SE |
| K843596 | Nidek-Binocular Indirect OphthalmoscopeHLI · Traditional | Nidek, Inc. | 02/15/1985SE |
| K844054 | Canon Auto Keratometer K-1HLI · Traditional | Canon USA, Inc. | 12/19/1984SE |
| K843812 | Woodlyn Classic Cataract Acuity TestHLI · Traditional | Woodlyn, Inc. | 12/11/1984SE |
| K843304 | Binocular Indirect OphthalmoscopeHLI · Traditional | Mentor O & O, Inc. | 11/21/1984SE |
| K843099 | Mamiya Slit Lamp P-1HLI · Traditional | Okada Corp. | 11/21/1984SE |
| K841767 | Woodlyn Classic KeratometerHLI · Traditional | Woodlyn, Inc. | 08/07/1984SE |
| K841764 | Woodlyn Classic Javal OphthalmometerHLI · Traditional | Woodlyn, Inc. | 08/07/1984SE |
| K841761 | Woodlyn Classic Slit Lamp Hssl-ClHLI · Traditional | Woodlyn, Inc. | 08/07/1984SE |
| K841763 | Woodlyn Slit Lamp Hssl-EcHLI · Traditional | Woodlyn, Inc. | 08/02/1984SE |
| K822104 | Alcon Indirect OphthalmoscopeHLI · Traditional | Alcon Laboratories | 08/10/1982SE |
| K791510 | Blue Field Entoptoscope BFE100HLI · Traditional | Medical Instrument Research Assoc., Inc. | 12/11/1979SE |
| K772214 | Ophthalmoscope, Binocular, IndirectHLI · Traditional | Varian Assoc., Inc. | 12/13/1977SE |
| K770768 | Ophthalmoscope, Model #11100HLI · Traditional | Welch Allyn, Inc. | 05/06/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0477-2022 Class II | OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4Malfunction of the automatic laser beam shut-off, the OCT unit might not recognize whether the laser beam is… | Haag-Streit USA Inc | 11/03/2021Open, Classified |
| Z-0010-2018 Class II | iVue 500 with iScan, D216606. Product non-contact, high resolution tomographic imaging…FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Optovue, Inc. | 07/27/2017Terminated |
| Z-0008-2018 Class II | iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue…FDA determined that a 510(k) is needed for the Vault Mapping software (also known as Lens Fitting). | Optovue, Inc. | 07/27/2017Terminated |
| Z-1498-2016 Class II | iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA…A software anomaly was detected that affects Optovue iVue and iVue 500 with Normative Database that may… | Optovue, Inc. | 03/16/2016Terminated |
| Z-1441-2013 Class III | Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1. Intended…Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in iVue version… | Optovue, Inc. | 05/14/2013Terminated |
| Z-2048-2009 | Stratus OCT Model 3000 instruments distributed with version 6.0.0 software, product…Mis-labeled image. A bug in version 6.0.0 software and 6.0.0 software kit used with Stratus OCT Model 3000… | Carl Zeiss Meditec Inc | 07/31/2009Terminated |
| Z-1132-2008 | Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device.… | Keeler Instruments Inc | 01/08/2008Terminated |