HLJ · Class II · 21 CFR 886.1570

FDA Product Code HLJ: Ophthalmoscope, Battery-powered

Leading manufacturers include Rudolf Riester GmbH & Co. KG, Neitz Instruments Company, Ltd. and Heine Optotechnik GmbH & Co. KG.

47
Total
47
Cleared
123d
Avg days
1976
Since

FDA 510(k) Cleared Ophthalmoscope, Battery-powered Devices (Product Code HLJ)

47 devices
1–24 of 47
Cleared May 18, 2015
HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
K142486
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 256d
Cleared Jan 29, 2015
HEINE SIGMA 250 & HEINE SIGMA 250 M2
K142837
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Mar 07, 2014
HEINE MINI 3000(R) OPHTHALMOSCOPE
K131959
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 253d
Cleared Dec 04, 2013
HEINE BETA 200(R) OPHTHALMOSCOPE
K131961
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 160d
Cleared Oct 30, 2013
OPHTHALMOSCOPES DIAGNOSTIC INSTRUMENT KITS
K131719
Medical Devices (Pvt) , Ltd.
Ophthalmic · 140d
Cleared Mar 22, 2013
HEINE MINI 3000 LED OPHTHALMOSCOPE
K123587
Heine Optotechnik GmbH & Co. KG
Ophthalmic · 121d
Cleared Nov 19, 2010
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
K093495
American Diagnostic Corp.
Ophthalmic · 374d
Cleared Nov 05, 2007
PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36
K070270
Kirchner & Wilhelm GmbH + Co.Kg
Ophthalmic · 280d
Cleared Nov 07, 2006
66 VISION TECH OPHTHALMOSCOPE, MODELS YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A
K052599
Suzhou 66 Vision-Tech Co., Ltd.
Ophthalmic · 412d
Cleared May 16, 2006
OPTYSE OPHTHALMOSCOPE
K061278
Ophthalmos , Ltd.
Ophthalmic · 8d
Cleared Jan 09, 2006
PRECISION OPTICS CORPORATION VIDEO OPHTHALMOSCOPE, MODEL 2500-VOS
K053425
Precision Optics Corp.
Ophthalmic · 32d
Cleared Nov 26, 2003
KEELER WIDE ANGLE OPHTHALMOSCOPE MODEL 1130-P-5004
K032087
Keeler Instruments, Inc.
Ophthalmic · 142d
Cleared Sep 12, 2000
MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
K002044
Magna Fortis Corporation
Ophthalmic · 69d
Cleared Jul 03, 1997
MS401097-17,MS722-K,MS720,MS721,MS722
K962767
Alexander Mfg. Co.
Ophthalmic · 352d
Cleared Apr 02, 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029
Keeler Instruments, Inc.
Ophthalmic · 89d
Cleared Jul 24, 1995
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
K950914
Rudolf Riester GmbH & Co. KG
Ophthalmic · 151d
Cleared Mar 28, 1995
HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134
K950797
Neitz Instruments Company, Ltd.
Ophthalmic · 35d
Cleared Mar 22, 1995
HALOGEN DIAGNOSTIC SET BX A - 12345
K950796
Neitz Instruments Company, Ltd.
Ophthalmic · 29d
Cleared Jan 17, 1995
RI-SCOPE S OTOSCOPE
K945640
Rudolf Riester GmbH & Co. KG
Ophthalmic · 62d
Cleared Nov 22, 1994
FOCOMETER
K944402
Lacrimedics, Inc.
Ophthalmic · 71d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13A
K942717
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN POCKET OPHTHALMOSCOPE A-JR
K942719
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-13
K942721
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Jun 03, 1994
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
K942034
R & D Batteries, Inc.
Ophthalmic · 36d

About Product Code HLJ - Regulatory Context