HLI — Ophthalmoscope, Ac-Powered Class II
FDA product code HLI covers "Ophthalmoscope, Ac-Powered", a Class II medical device regulated under 21 CFR 886.1570. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |