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) → HLJ — Ophthalmoscope, Battery-Powered # HLJ · Ophthalmoscope, Battery-Powered _Ophthalmic · 21 CFR 886.1570 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ ## Overview - **Product Code:** HLJ - **Device Name:** Ophthalmoscope, Battery-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 47) Showing 20 most recent of 47 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K142486](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K142486.md) | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | Heine Optotechnik GmbH & Co. KG | May 18, 2015 | SESE | | [K142837](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K142837.md) | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | Heine Optotechnik GmbH & Co. KG | Jan 29, 2015 | SESE | | [K131959](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K131959.md) | HEINE MINI 3000(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | Mar 7, 2014 | SESE | | [K131961](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K131961.md) | HEINE BETA 200(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | Dec 4, 2013 | SESE | | [K131719](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K131719.md) | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | Medical Devices (Pvt) , Ltd. | Oct 30, 2013 | SESE | | [K123587](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K123587.md) | HEINE MINI 3000 LED OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | Mar 22, 2013 | SESE | | [K093495](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K093495.md) | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | American Diagnostic Corp. | Nov 19, 2010 | SESE | | [K070270](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K070270.md) | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | Kirchner & Wilhelm GmbH + Co.Kg | Nov 5, 2007 | SESE | | [K052599](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K052599.md) | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A | Suzhou 66 Vision Tech Co., Ltd. | Nov 7, 2006 | SESE | | [K061278](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K061278.md) | OPTYSE OPHTHALMOSCOPE | Ophthalmos , Ltd. | May 16, 2006 | SESE | | [K053425](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K053425.md) | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | Precision Optics Corp. | Jan 9, 2006 | SESE | | [K032087](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K032087.md) | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Keeler Instruments, Inc. | Nov 26, 2003 | SESE | | [K002044](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K002044.md) | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | Magna Fortis Corporation | Sep 12, 2000 | SESE | | [K962767](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K962767.md) | MS401097-17,MS722-K,MS720,MS721,MS722 | Alexander Mfg. Co. | Jul 3, 1997 | SESE | | [K970029](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K970029.md) | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | Apr 2, 1997 | SESE | | [K950914](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K950914.md) | RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V | Rudolf Riester GmbH & Co. KG | Jul 24, 1995 | SESE | | [K950797](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K950797.md) | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Neitz Instruments Company, Ltd. | Mar 28, 1995 | SESE | | [K950796](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K950796.md) | HALOGEN DIAGNOSTIC SET BX A - 12345 | Neitz Instruments Company, Ltd. | Mar 22, 1995 | SESE | | [K945640](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K945640.md) | RI-SCOPE S OTOSCOPE | Rudolf Riester GmbH & Co. KG | Jan 17, 1995 | SESK | | [K944402](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ/K944402.md) | FOCOMETER | Lacrimedics, Inc. | Nov 22, 1994 | SESE | ## Top Applicants - Rudolf Riester GmbH & Co. KG — 6 clearances - Heine Optotechnik GmbH & Co. KG — 5 clearances - Neitz Instruments Company, Ltd. — 5 clearances - Design Med. Corp. — 3 clearances - Keeler Instruments, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HLJ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com