HLI · Class II · 21 CFR 886.1570

FDA Product Code HLI: Ophthalmoscope, Ac-powered

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

87
Total
87
Cleared
105d
Avg days
1977
Since
87 devices
73–87 of 87
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
MAMIYA SLIT LAMP P-1
K843099
Okada Corp.
Ophthalmic · 106d
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 11, 1979
BLUE FIELD ENTOPTOSCOPE BFE100
K791510
Medical Instrument Research Assoc., Inc.
Ophthalmic · 131d
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