HLI · Class II · 21 CFR 886.1570

FDA Product Code HLI: Ophthalmoscope, Ac-powered

Leading manufacturers include Carl Zeiss Meditec, Inc., Optovue, Inc. and Neitz Instruments Company, Ltd..

87
Total
87
Cleared
105d
Avg days
1977
Since
87 devices
49–72 of 87
Cleared Jan 06, 1992
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
K914484
Hgm Medical Laser Systems, Inc.
Ophthalmic · 90d
Cleared Dec 23, 1991
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581
Carl Zeiss, Inc.
Ophthalmic · 194d
Cleared Mar 23, 1990
KEELER KONAN SPECULAR MICROSCOPE SP3300
K900111
Keeler Instruments, Inc.
Ophthalmic · 73d
Cleared Sep 11, 1989
MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE
K895010
Mentor O & O, Inc.
Ophthalmic · 34d
Cleared Jun 05, 1989
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared Jun 05, 1989
VISTA SPECIALIST OPHTHALMOSCOPE (BATTERY & AC)
K893173
Keeler Instruments, Inc.
Ophthalmic · 41d
Cleared Nov 12, 1985
THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE
K854244
Keeler Instruments, Inc.
Ophthalmic · 22d
Cleared May 01, 1985
AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP
K851263
American Medical Optics
Ophthalmic · 34d
Cleared May 01, 1985
AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS
K851264
American Medical Optics
Ophthalmic · 34d
Cleared Apr 30, 1985
AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA
K851262
American Medical Optics
Ophthalmic · 33d
Cleared Feb 15, 1985
NIDEK-BINOCULAR INDIRECT OPHTHALMOSCOPE
K843596
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
NIDEK MONOCULAR INDIRECT OPHTHALMOSCOPE
K843597
Nidek, Inc.
Ophthalmic · 156d
Cleared Feb 15, 1985
MONOCULAR DIRECT OPHTHALMOSCOPE
K844971
Nidek, Inc.
Ophthalmic · 53d
Cleared Dec 19, 1984
CANON AUTO KERATOMETER K-1
K844054
Canon USA, Inc.
Ophthalmic · 62d
Cleared Dec 11, 1984
WOODLYN CLASSIC CATARACT ACUITY TEST
K843812
Woodlyn, Inc.
Ophthalmic · 74d
Cleared Nov 21, 1984
BINOCULAR INDIRECT OPHTHALMOSCOPE
K843304
Mentor O & O, Inc.
Ophthalmic · 90d
Cleared Aug 07, 1984
WOODLYN CLASSIC SLIT LAMP HSSL-CL
K841761
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN CLASSIC JAVAL OPHTHALMOMETER
K841764
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 07, 1984
WOODLYN CLASSIC KERATOMETER
K841767
Woodlyn, Inc.
Ophthalmic · 102d
Cleared Aug 02, 1984
WOODLYN SLIT LAMP HSSL-EC
K841763
Woodlyn, Inc.
Ophthalmic · 97d
Cleared Aug 10, 1982
ALCON INDIRECT OPHTHALMOSCOPE
K822104
Alcon Laboratories
Ophthalmic · 22d
Cleared Dec 13, 1977
OPHTHALMOSCOPE, BINOCULAR, INDIRECT
K772214
Varian Assoc., Inc.
Ophthalmic · 11d
Cleared May 06, 1977
OPHTHALMOSCOPE, MODEL #11100
K770768
Welch Allyn, Inc.
Ophthalmic · 8d