Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570) → HLI — Ophthalmoscope, Ac-Powered # HLI · Ophthalmoscope, Ac-Powered _Ophthalmic · 21 CFR 886.1570 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI ## Overview - **Product Code:** HLI - **Device Name:** Ophthalmoscope, Ac-Powered - **Regulation:** [21 CFR 886.1570](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1570) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K153080.md) | RTVue XR OCT Avanti with AngioVue Software | Optovue, Inc. | Feb 11, 2016 | SESE | | [K150722](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K150722.md) | EnFocus 2300, EnFocus 4400 | Bioptigen, Inc. | Dec 2, 2015 | SESE | | [K142953](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K142953.md) | OCT-Camera | Optomedical Technologies GmbH | Mar 4, 2015 | SESE | | [K141638](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K141638.md) | PROPPER INSIGHT BINOCULAR INDIRECT OPHTHALMOSOPE | Propper Manufacturing Co., Inc. | Sep 17, 2014 | SESE | | [K133758](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K133758.md) | CENTERVUE MACULAR INTEGRITY ASSESSMENT | Centervue S.P.A. | Apr 23, 2014 | SESE | | [K131939](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K131939.md) | AMICO DH-W35 OPHTHALMOSCOPE SERIES | Amico Diagnostic Incorporated | Mar 26, 2014 | SESE | | [K133892](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K133892.md) | IVUE 500 | Optovue, Inc. | Mar 19, 2014 | SESE | | [K123316](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K123316.md) | HEINE OMEGA 500 | Heine Optotechnik GmbH & Co. KG | Feb 26, 2013 | SESE | | [K121739](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K121739.md) | IVUE WITH NORMATIVE DATABASE | Optovue, Inc. | Jan 18, 2013 | SESE | | [K120057](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K120057.md) | ENVISU SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM (SDOIS) | Bioptigen, Inc. | May 11, 2012 | SESE | | [K120238](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K120238.md) | RTVUE XR OCT | Optovue, Inc. | Apr 3, 2012 | SESE | | [K111531](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K111531.md) | RHA2020 | Annidis Health Systems Corp. | Jul 8, 2011 | SESE | | [K103266](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K103266.md) | ISTAND | Optovue, Inc. | Jun 3, 2011 | SESE | | [K110205](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K110205.md) | AAIO-7, AAIO WIRLESS | Appasamy Associates | Feb 9, 2011 | SESE | | [K101505](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K101505.md) | RTVUE MODEL RTVUE 100 | Optovue, Inc. | Sep 15, 2010 | SESE | | [K100861](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K100861.md) | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Optovue, Inc. | Jun 17, 2010 | SESE | | [K063378](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K063378.md) | CIRRUS HD-OCT, MODEL 4000 | Carl Zeiss Meditec, Inc. | Jan 26, 2007 | SESE | | [K063343](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K063343.md) | BIOPTIGEN SPECTRAL DOMAIN OPHTHALMIC IMAGING SYSTEM | Bioptigen, Inc. | Dec 13, 2006 | SESE | | [K061674](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K061674.md) | RTA 5 & RTA MODEL E RETINAL THICKNESS ANALYZER | Talia Technology , Ltd. | Aug 23, 2006 | SESE | | [K060822](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI/K060822.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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