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
49–72 of 87
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RC
K942715
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-12
K942720
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 04, 1994
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104
Keeler Instruments, Inc.
Ophthalmic · 94d
Cleared Jul 18, 1994
NERVE FIBER ANALYZER
K941705
Carl Zeiss Meditec, Inc.
Ophthalmic · 103d
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 Mar 26, 1993
TOPOGRAPHIC SCANNING SYSTEM TOPSS
K923742
Carl Zeiss Meditec, Inc.
Ophthalmic · 242d
Cleared Oct 27, 1992
REGALTECH MAXISCOPE
K921163
Regaltech Pty. , Ltd.
Ophthalmic · 230d
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 Oct 23, 1991
PROFESSIONAL INDIRECT OPHTHALMOSCOPE
K912397
Clement Clarke, Inc.
Ophthalmic · 148d
Cleared Oct 09, 1991
GLAUCOMA-SCOPE
K913118
Ophthalmic Imaging Systems
Ophthalmic · 86d
Cleared Sep 27, 1991
HEIDELBERG RETINA TOMOGRAPH
K912891
Heidelberg Engineering
Ophthalmic · 88d
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 Jan 24, 1989
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K882517
Rodenstock Instrument Corp.
Ophthalmic · 221d
Cleared Sep 06, 1988
EOL, MODEL LIO
K881984
Eol, Inc.
Ophthalmic · 117d
Cleared Jun 10, 1987
RODENSTOCK SCANNING LASER OPHTHALMOSCOPE
K871268
G. Rodenstock Instrumente GmbH
Ophthalmic · 71d
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