FDA 510(k) Applications for Medical Device Product Code "HLI"
(Ophthalmoscope, Ac-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K131939 | AMICO DIAGNOSTIC INCORPORATED | AMICO DH-W35 OPHTHALMOSCOPE SERIES | 03/26/2014 |
| K111531 | ANNIDIS HEALTH SYSTEMS CORP. | RHA2020 | 07/08/2011 |
| K110205 | APPASAMY ASSOCIATES | AAIO-7, AAIO WIRLESS | 02/09/2011 |
| K063343 | BIOPTIGEN, INC. | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | 12/13/2006 |
| K150722 | BIOPTIGEN, INC. | EnFocus 2300, EnFocus 4400 | 12/02/2015 |
| K120057 | BIOPTIGEN, INC. | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | 05/11/2012 |
| K992606 | CANON U.S.A., INC. | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | 06/21/2000 |
| K063378 | CARL ZEISS MEDITEC INC | CIRRUS HD-OCT, MODEL 4000 | 01/26/2007 |
| K033123 | CARL ZEISS MEDITEC INC | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE | 04/20/2004 |
| K030433 | CARL ZEISS MEDITEC INC | STRATUSOCT WITH RNFL NORMATIVE DATABASE | 05/01/2003 |
| K051789 | CARL ZEISS MEDITEC INC | VISANTE OCT | 09/30/2005 |
| K961171 | CARL ZEISS, INC. | HUMPHREY OCT SCANNER | 06/21/1996 |
| K133758 | CENTERVUE SPA | CENTERVUE MACULAR INTEGRITY ASSESSMENT | 04/23/2014 |
| K994340 | HAI LABORATORIES, INC. | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ | 09/20/2000 |
| K971671 | HEIDELBERG ENGINEERING | HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C) | 07/29/1997 |
| K123316 | HEINE OPTOTECHNIK GMBH & CO. KG. | HEINE OMEGA 500 | 02/26/2013 |
| K060822 | KEELER INSTRUMENTS, INC. | VANTAGE INDIRECT OPHTHALMOSCOPE | 05/23/2006 |
| K951728 | MIRA, INC. | SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE | 03/19/1997 |
| K981640 | ODYSSEY OPTICAL SYSTEMS, LLC. | S2LO | 08/05/1998 |
| K042885 | OPHTHALMIC TECHNOLOGIES, INC. | OCT-OPTHALMOSCOPE | 01/21/2005 |
| K142953 | OptoMedical Technologies GmbH | OCT-Camera | 03/04/2015 |
| K042001 | OPTOS PLC | PANORAMIC 200A | 10/07/2004 |
| K983999 | OPTOS PLC | PANORAMIC200 OPTHALMOSCOPE | 02/03/1999 |
| K103266 | OPTOVUE, INC. | ISTAND | 06/03/2011 |
| K133892 | OPTOVUE, INC. | IVUE 500 | 03/19/2014 |
| K121739 | OPTOVUE, INC. | IVUE WITH NORMATIVE DATABASE | 01/18/2013 |
| K100861 | OPTOVUE, INC. | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | 06/17/2010 |
| K101505 | OPTOVUE, INC. | RTVUE MODEL RTVUE 100 | 09/15/2010 |
| K120238 | OPTOVUE, INC. | RTVUE XR OCT | 04/03/2012 |
| K153080 | OPTOVUE, INC. | RTVue XR OCT Avanti with AngioVue Software | 02/11/2016 |
| K141638 | PROPPER MANUFACTURING CO.,INC. | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | 09/17/2014 |
| K000731 | TALIA TECHNOLOGY LTD. | MODIFICATION TO RTA RETINAL THICKNESS ANALYZER | 03/31/2000 |
| K061674 | TALIA TECHNOLOGY LTD. | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | 08/23/2006 |
| K031312 | TALIA TECHNOLOGY LTD. | RTA MODEL D RETINAL THICKNESS ANALYZER | 05/06/2003 |
| K041290 | TALIA TECHNOLOGY LTD. | RTA MODEL D RETINAL THICKNESS ANALYZER | 05/24/2004 |
| K964137 | TALIA TECHNOLOGY LTD. | RTA RETINAL THICKNESS ANALYZER | 02/03/1997 |
| K003376 | WELCH ALLYN, INC. | WELCH ALLYN 11800 OPTHALMOSCOPE | 01/25/2001 |
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