HLJ · Ophthalmoscope, Battery-Powered
Ophthalmic · 21 CFR 886.1570 · Class 2
Overview
| Product Code | HLJ |
|---|---|
| Device Name | Ophthalmoscope, Battery-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 47)
Showing 20 most recent of 47 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | Heine Optotechnik GmbH & Co. KG | May 18, 2015 | SESE |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | Heine Optotechnik GmbH & Co. KG | Jan 29, 2015 | SESE |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | Mar 7, 2014 | SESE |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | Dec 4, 2013 | SESE |
| K131719 | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | Medical Devices (Pvt) , Ltd. | Oct 30, 2013 | SESE |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | Mar 22, 2013 | SESE |
| K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | American Diagnostic Corp. | Nov 19, 2010 | SESE |
| K070270 | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | Kirchner & Wilhelm GmbH + Co.Kg | Nov 5, 2007 | SESE |
| K052599 | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A | Suzhou 66 Vision Tech Co., Ltd. | Nov 7, 2006 | SESE |
| K061278 | OPTYSE OPHTHALMOSCOPE | Ophthalmos , Ltd. | May 16, 2006 | SESE |
| K053425 | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | Precision Optics Corp. | Jan 9, 2006 | SESE |
| K032087 | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | Keeler Instruments, Inc. | Nov 26, 2003 | SESE |
| K002044 | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | Magna Fortis Corporation | Sep 12, 2000 | SESE |
| K962767 | MS401097-17,MS722-K,MS720,MS721,MS722 | Alexander Mfg. Co. | Jul 3, 1997 | SESE |
| K970029 | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | Keeler Instruments, Inc. | Apr 2, 1997 | SESE |
| K950914 | 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 | HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134 | Neitz Instruments Company, Ltd. | Mar 28, 1995 | SESE |
| K950796 | HALOGEN DIAGNOSTIC SET BX A - 12345 | Neitz Instruments Company, Ltd. | Mar 22, 1995 | SESE |
| K945640 | RI-SCOPE S OTOSCOPE | Rudolf Riester GmbH & Co. KG | Jan 17, 1995 | SESK |
| K944402 | 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
