HKI · Class II · 21 CFR 886.1120

FDA Product Code HKI: Camera, Ophthalmic, Ac-powered

Leading manufacturers include Canon USA, Inc., Canon, Inc. and Nidek, Inc..

157
Total
157
Cleared
123d
Avg days
1977
Since
157 devices
49–72 of 157
Cleared Feb 22, 1994
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663
Canon USA, Inc.
Ophthalmic · 147d
Cleared Jan 23, 1992
CANDELA RETINAL CAMERA
K913314
Candela Laser Corp.
Ophthalmic · 182d
Cleared Jun 17, 1991
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439
Canon USA, Inc.
Ophthalmic · 76d
Cleared Oct 04, 1989
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474
Canon USA, Inc.
Ophthalmic · 23d
Cleared Nov 02, 1987
MODIFIED RETINAL CAMERA MODEL CR4-45NM
K874017
Canon USA, Inc.
Ophthalmic · 31d
Cleared Aug 21, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR4-45NM
K862323
Canon USA, Inc.
Ophthalmic · 63d
Cleared Feb 27, 1986
CANON NON-MYDRIATIC RETINAL CAMERA CR3-45NM
K855170
Canon USA, Inc.
Ophthalmic · 63d
Cleared Jan 28, 1985
GRC-WT, GRC-W
K843899
Olympus Corp.
Ophthalmic · 117d
Cleared Jan 22, 1985
CANON 60 ZOOM FUNDUS CAMERA CF-60ZA OPHTHALMIC CAM
K844898
Canon USA, Inc.
Ophthalmic · 36d
Cleared Oct 05, 1984
CANON 60 FUNDUS CAMERA CF-60U
K843021
Canon USA, Inc.
Ophthalmic · 65d
Cleared Feb 24, 1983
AO DOCUSTAR(MMIRO) FUNDUS CAMERA
K822991
Warner-Lambert Co.
Ophthalmic · 135d