HLI — Ophthalmoscope, Ac-Powered Class II
FDA Device Classification
Classification Details
- Product Code
- HLI
- Device Class
- Class II
- Regulation Number
- 886.1570
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K153080 | optovue | RTVue XR OCT Avanti with AngioVue Software | February 11, 2016 |
| K150722 | bioptigen | EnFocus 2300, EnFocus 4400 | December 2, 2015 |
| K142953 | optomedical technologies | OCT-Camera | March 4, 2015 |
| K141638 | propper manufacturing co | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | September 17, 2014 |
| K133758 | centervue | CENTERVUE MACULAR INTEGRITY ASSESSMENT | April 23, 2014 |
| K131939 | amico diagnostic incorporated | AMICO DH-W35 OPHTHALMOSCOPE SERIES | March 26, 2014 |
| K133892 | optovue | IVUE 500 | March 19, 2014 |
| K123316 | heine optotechnik gmbh and co. kg | HEINE OMEGA 500 | February 26, 2013 |
| K121739 | optovue | IVUE WITH NORMATIVE DATABASE | January 18, 2013 |
| K120057 | bioptigen | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | May 11, 2012 |
| K120238 | optovue | RTVUE XR OCT | April 3, 2012 |
| K111531 | annidis health systems | RHA2020 | July 8, 2011 |
| K103266 | optovue | ISTAND | June 3, 2011 |
| K110205 | appasamy associates | AAIO-7, AAIO WIRLESS | February 9, 2011 |
| K101505 | optovue | RTVUE MODEL RTVUE 100 | September 15, 2010 |
| K100861 | optovue | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | June 17, 2010 |
| K063378 | carl zeiss meditec | CIRRUS HD-OCT, MODEL 4000 | January 26, 2007 |
| K063343 | bioptigen | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | December 13, 2006 |
| K061674 | talia technology | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | August 23, 2006 |
| K060822 | keeler instruments | VANTAGE INDIRECT OPHTHALMOSCOPE | May 23, 2006 |