FDA 510(k) Applications for Medical Device Product Code "HLJ"
(Ophthalmoscope, Battery-Powered)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K962767 | ALEXANDER MFG. CO. | MS401097-17,MS722-K,MS720,MS721,MS722 | 07/03/1997 |
| K093495 | AMERICAN DIAGNOSTIC CORP. | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | 11/19/2010 |
| K142486 | HEINE Optotechnik GmbH & Co. KG | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | 05/18/2015 |
| K142837 | HEINE Optotechnik GmbH & Co. KG | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | 01/29/2015 |
| K131961 | HEINE OPTOTECHNIK GMBH & CO. KG. | HEINE BETA 200(R) OPHTHALMOSCOPE | 12/04/2013 |
| K123587 | HEINE OPTOTECHNIK GMBH & CO. KG. | HEINE MINI 3000 LED OPHTHALMOSCOPE | 03/22/2013 |
| K131959 | HEINE OPTOTECHNIK GMBH & CO. KG. | HEINE MINI 3000(R) OPHTHALMOSCOPE | 03/07/2014 |
| K970029 | KEELER INSTRUMENTS, INC. | KEELER SPECTRA INDIRECT OPHTHALMOSCOPE | 04/02/1997 |
| K032087 | KEELER INSTRUMENTS, INC. | KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004 | 11/26/2003 |
| K070270 | KIRCHNER & WILHELM GMBH + CO.KG | PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 | 11/05/2007 |
| K002044 | MAGNA FORTIS CORPORATION | MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT | 09/12/2000 |
| K131719 | MEDICAL DEVICES (PVT) LTD. | OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS | 10/30/2013 |
| K061278 | OPHTHALMOS LTD. | OPTYSE OPHTHALMOSCOPE | 05/16/2006 |
| K053425 | PRECISION OPTICS CORP. | PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS | 01/09/2006 |
| K052599 | SUZHOU 66 VISION TECH CO., LTD. | 66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A | 11/07/2006 |
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