HLI · Ophthalmoscope, Ac-Powered
Ophthalmic · 21 CFR 886.1570 · Class 2
Overview
| Product Code | HLI |
|---|---|
| Device Name | Ophthalmoscope, Ac-Powered |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
Classification Rationale
Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Recent Cleared Devices (20 of 87)
Showing 20 most recent of 87 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K153080 | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | Feb 11, 2016 | SESE |
| K150722 | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | Dec 2, 2015 | SESE |
| K142953 | OCT-Camera | Optomedical Technologies GmbH | Mar 4, 2015 | SESE |
| K141638 | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | Sep 17, 2014 | SESE |
| K133758 | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | Apr 23, 2014 | SESE |
| K131939 | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Amico Diagnostic Incorporated | Mar 26, 2014 | SESE |
| K133892 | IVUE 500 | Optovue, Inc. | Mar 19, 2014 | SESE |
| K123316 | HEINE OMEGA 500 | Heine Optotechnik GmbH & Co. KG | Feb 26, 2013 | SESE |
| K121739 | IVUE WITH NORMATIVE DATABASE | Optovue, Inc. | Jan 18, 2013 | SESE |
| K120057 | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | May 11, 2012 | SESE |
| K120238 | RTVUE XR OCT | Optovue, Inc. | Apr 3, 2012 | SESE |
| K111531 | RHA2020 | Annidis Health Systems Corp. | Jul 8, 2011 | SESE |
| K103266 | ISTAND | Optovue, Inc. | Jun 3, 2011 | SESE |
| K110205 | AAIO-7, AAIO WIRLESS | Appasamy Associates | Feb 9, 2011 | SESE |
| K101505 | RTVUE MODEL RTVUE 100 | Optovue, Inc. | Sep 15, 2010 | SESE |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Optovue, Inc. | Jun 17, 2010 | SESE |
| K063378 | CIRRUS HD-OCT, MODEL 4000 | Carl Zeiss Meditec, Inc. | Jan 26, 2007 | SESE |
| K063343 | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Bioptigen, Inc. | Dec 13, 2006 | SESE |
| K061674 | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | Aug 23, 2006 | SESE |
| K060822 | VANTAGE INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | May 23, 2006 | SESE |
Top Applicants
- Optovue, Inc. — 7 clearances
- Neitz Instruments Company, Ltd. — 7 clearances
- Carl Zeiss Meditec, Inc. — 7 clearances
- Keeler Instruments, Inc. — 6 clearances
- Woodlyn, Inc. — 5 clearances
