Product code HLI
- Device name
- Ophthalmoscope, Ac-Powered
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.1570
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | 2016-02-11 |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | 2015-12-02 |
| K142953 | OCT-Camera | Optomedical Technologies GmbH | 2015-03-04 |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | 2014-09-17 |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | 2014-04-23 |
| K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Amico Diagnostic Incorporated | 2014-03-26 |
| K133892 | IVUE 500 | Optovue, Inc. | 2014-03-19 |
| K123316 | HEINE OMEGA 500 | Heine Optotechnik GmbH & Co. KG | 2013-02-26 |
| K121739 | IVUE WITH NORMATIVE DATABASE | Optovue, Inc. | 2013-01-18 |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | 2012-05-11 |
| K120238 | RTVUE XR OCT | Optovue, Inc. | 2012-04-03 |
| K111531 | RHA2020 | Annidis Health Systems Corp. | 2011-07-08 |
| K103266 | ISTAND | Optovue, Inc. | 2011-06-03 |
| K110205 | AAIO-7, AAIO WIRLESS | Appasamy Associates | 2011-02-09 |
| K101505 | RTVUE MODEL RTVUE 100 | Optovue, Inc. | 2010-09-15 |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Optovue, Inc. | 2010-06-17 |
| K063378 | CIRRUS HD-OCT, MODEL 4000 | Carl Zeiss Meditec, Inc. | 2007-01-26 |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Bioptigen, Inc. | 2006-12-13 |
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2006-08-23 |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | 2006-05-23 |
| K051789 | VISANTE OCT | Carl Zeiss Meditec, Inc. | 2005-09-30 |
| K042885 | OCT-OPTHALMOSCOPE | Ophthalmic Technologies, Inc. | 2005-01-21 |
| K042001 | PANORAMIC 200A | Optos Plc. | 2004-10-07 |
| K041290 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2004-05-24 |
| K033123 | STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2004-04-20 |
| K031312 | RTA MODEL D RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | 2003-05-06 |
| K030433 | STRATUSOCT WITH RNFL NORMATIVE DATABASE | Carl Zeiss Meditec, Inc. | 2003-05-01 |
| K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | Welch Allyn, Inc. | 2001-01-25 |
| K994340 | CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ | Hai Laboratories, Inc. | 2000-09-20 |
| K992606 | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 | Canon USA, Inc. | 2000-06-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00697077002237 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2023-07-27 |
| 00697077002527 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2020-02-24 |
| 00697077002480 | Amico Diagnostic Rollstand | Amico Diagnostic Incorporated | 2019-03-26 |
| 00697077002473 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2019-03-15 |
| 00697077002442 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2019-01-22 |
| 00697077002428 | Amico Diagnostic Rollstand | Amico Diagnostic Incorporated | 2019-01-22 |
| 00697077002398 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2018-05-17 |
| 00697077002374 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2018-04-03 |
| 00697077002367 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2018-04-03 |
| 00697077002336 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2018-03-22 |
| 00697077002343 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2018-03-22 |
| 00697077002312 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2018-03-15 |
| 00697077002251 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2017-09-20 |
| 00697077002282 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2017-09-20 |
| 00697077002213 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2017-08-22 |
| 00697077002220 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2017-08-22 |
| 00697077002206 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2017-08-14 |
| 00697077002190 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2017-07-20 |
| 00697077002060 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2017-07-10 |
| 00697077002077 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2017-07-10 |
| 00697077002039 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2017-04-13 |
| 00697077001995 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2016-10-14 |
| 00697077001070 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2016-09-24 |
| 00697077001513 | Amico Diagnostic Wallboard | Amico Diagnostic Incorporated | 2016-09-24 |
| 00697077001131 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2016-09-24 |
| 00697077001124 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2016-09-24 |
| 00697077001094 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2016-09-24 |
| 00697077001087 | Amico Diagnostic Station | Amico Diagnostic Incorporated | 2016-09-24 |
| 00858848006001 | Avanti | OPTOVUE, INC. | 2016-08-31 |
| 00627843652021 | RHA | Annidis Health Systems Corp | 2016-08-05 |