HLI · Class II · 21 CFR 886.1570

FDA Product Code HLI: Ophthalmoscope, Ac-powered

Leading manufacturers include Keeler Instruments, Inc., Welch Allyn, Inc. and Nidek, Inc..

87
Total
87
Cleared
105d
Avg days
1977
Since

FDA 510(k) Cleared Ophthalmoscope, Ac-powered Devices (Product Code HLI)

87 devices
1–24 of 87
Cleared May 23, 2006
VANTAGE INDIRECT OPHTHALMOSCOPE
K060822
Keeler Instruments, Inc.
Ophthalmic · 57d
Cleared Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Jun 21, 2000
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606
Canon USA, Inc.
Ophthalmic · 323d
Cleared Jun 21, 1996
HUMPHREY OCT SCANNER
K961171
Carl Zeiss, Inc.
Radiology · 88d
Cleared Jun 06, 1995
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210
Welch Allyn, Inc.
Ophthalmic · 81d
Cleared Apr 04, 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461
Welch Allyn, Inc.
Ophthalmic · 60d
Cleared Aug 04, 1994
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104
Keeler Instruments, Inc.
Ophthalmic · 94d
Cleared Feb 22, 1994
R&D BATTERIES # 5615, 5234, 5097
K935988
R & D Batteries, Inc.
Ophthalmic · 70d
Cleared Jun 21, 1993
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
K930023
Welch Allyn, Inc.
Ophthalmic · 167d
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 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 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 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

About Product Code HLI - Regulatory Context