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
25–48 of 87
Cleared Apr 20, 2004
STRATUSOCT WITH RNFL & MACULA NORMATIVE DATABASE
K033123
Carl Zeiss Meditec, Inc.
Radiology · 203d
Cleared May 06, 2003
RTA MODEL D RETINAL THICKNESS ANALYZER
K031312
Talia Technology , Ltd.
Ophthalmic · 12d
Cleared May 01, 2003
STRATUSOCT WITH RNFL NORMATIVE DATABASE
K030433
Carl Zeiss Meditec, Inc.
Ophthalmic · 80d
Cleared Jan 25, 2001
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376
Welch Allyn, Inc.
Ophthalmic · 87d
Cleared Sep 20, 2000
CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ
K994340
Hai Laboratories, Inc.
Ophthalmic · 272d
Cleared Jun 21, 2000
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606
Canon USA, Inc.
Ophthalmic · 323d
Cleared Mar 31, 2000
MODIFICATION TO RTA RETINAL THICKNESS ANALYZER
K000731
Talia Technology , Ltd.
Ophthalmic · 25d
Cleared Feb 03, 1999
PANORAMIC200 OPTHALMOSCOPE
K983999
Optos Plc.
Ophthalmic · 86d
Cleared Aug 05, 1998
S2LO
K981640
Odyssey Optical Systems, LLC
Ophthalmic · 89d
Cleared Jul 29, 1997
HEIDELBERG RETINA ANGIOGRAPH FA/ICGA (HRA/C)
K971671
Heidelberg Engineering
Ophthalmic · 83d
Cleared Mar 19, 1997
SCHEPENS-YOSHIDA VIDEO BINOCULAR INDIRECT OPHTHALMSCOPE
K951728
Mira, Inc.
Ophthalmic · 706d
Cleared Feb 03, 1997
RTA RETINAL THICKNESS ANALYZER
K964137
Talia Technology , Ltd.
Ophthalmic · 111d
Cleared Jun 21, 1996
HUMPHREY OCT SCANNER
K961171
Carl Zeiss, Inc.
Radiology · 88d
Cleared Jun 26, 1995
ANGIOSCAN (AS STAND ALONE INSTRUMENT)
K951132
Carl Zeiss Meditec, Inc.
Ophthalmic · 105d
Cleared Jun 06, 1995
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210
Welch Allyn, Inc.
Ophthalmic · 81d
Cleared Apr 07, 1995
INDIRECT OPHTHALMOSCOPE VIDEO SYSTEM IO0 A TV
K951338
Neitz Instruments Company, Ltd.
Ophthalmic · 14d
Cleared Apr 04, 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461
Welch Allyn, Inc.
Ophthalmic · 60d
Cleared Nov 14, 1994
RETINA FLOWMETER
K943955
Heidelberg Engineering
Ophthalmic · 91d
Cleared Nov 14, 1994
RETINA TOMOGRAPH AND FLOWMETER
K943956
Heidelberg Engineering
Ophthalmic · 91d
Cleared Nov 14, 1994
RETINA ANGIOGRAPH
K944261
Heidelberg Engineering
Ophthalmic · 74d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
K942711
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-A
K942712
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN BINOCULAR INDIRECT OPHTHALMOSCOPE IO-H
K942713
Neitz Instruments Company, Ltd.
Ophthalmic · 57d
Cleared Aug 05, 1994
NEITZ HALOGEN OPHTHALMOSCOPE BXA-RP
K942714
Neitz Instruments Company, Ltd.
Ophthalmic · 57d