HKI · Class II · 21 CFR 886.1120

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

Leading manufacturers include Canon USA, Inc., Kowa Co. , Ltd. and Canon, Inc..

157
Total
157
Cleared
123d
Avg days
1977
Since
157 devices
25–48 of 157
Cleared Sep 10, 2019
KOWA nonmyd 8
K191945
Kowa Company , Ltd.
Ophthalmic · 50d
Cleared Jun 04, 2019
KOWA DR-1a
K190573
Kowa Company , Ltd.
Ophthalmic · 90d
Cleared Apr 01, 2019
Microperimeter MP-3, Microperimeter MP-3 Type S
K190198
Nidek Co., Ltd.
Ophthalmic · 56d
Cleared Jan 02, 2019
NFC-700 non-mydriatic auto fundus camera
K182199
Crystalvue Medical Corporation
Ophthalmic · 141d
Cleared Dec 21, 2018
3nethra neo
K183059
Forus Health Pvt.Ltd
Ophthalmic · 49d
Cleared Dec 10, 2018
LipiScan Dynamic Meibomian Imager
K182506
Tearscience, Inc.
Ophthalmic · 89d
Cleared Sep 07, 2018
RetCam 3
K182263
Natus Medical Incorporated
Ophthalmic · 17d
Cleared Jul 27, 2018
RetiCapture
K173474
Ilooda Co,., Ltd.
Ophthalmic · 260d
Cleared Jun 08, 2018
Nexy
K180306
Next Sight Srl
Ophthalmic · 126d
Cleared Apr 05, 2018
Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
K180378
Optomed OY
Ophthalmic · 52d
Cleared Sep 15, 2017
Phoenix Clinical ICON
K170527
Phoenix Technology Group, Inc. Dba Phoenix Clinical
Ophthalmic · 205d
Cleared Apr 11, 2017
HAAG-STREIT FUNDUS MODULE 300
K163021
Optomed OY
Ophthalmic · 162d
Cleared Oct 04, 2016
Eyenez Ophthalmic Camera
K161727
Eyenez, LLC
Ophthalmic · 104d
Cleared Jun 06, 2016
MICROPERIMETER MP-3
K152729
Nidek Co., Ltd.
Ophthalmic · 258d
Cleared May 12, 2016
LSFG-NAVI
K153239
Softcare Co., Ltd.
Ophthalmic · 185d
Cleared Jan 14, 2016
LipiView II Ocular Surface Interferometer
K152869
Tearscience, Inc.
Ophthalmic · 106d
Cleared Oct 23, 2014
TRC-NW8F PLUS NON-MYDRIATIC RETINAL CAMERA
K141325
Topcon Corp.
Ophthalmic · 156d
Cleared Sep 17, 2014
TRC-NW400 NON-MYDRIATIC RETINAL CAMERA
K141481
Topcon Corporation
Ophthalmic · 105d
Cleared Jul 03, 2014
COBRA FUNDUS CAMERA
K132987
C.S.O. S.R.L.
Ophthalmic · 282d
Cleared Jun 17, 2014
KEELER KAPTURE SOFTWARE
K140450
Keeler Limited
Ophthalmic · 113d
Cleared Dec 18, 2013
OPTOMED SMARTSCOPE M5 / OPTOMED SMARTSCOPE EY4 / OPTOMED SMARTSCOPE ES2
K132186
Optomed OY
Ophthalmic · 156d
Cleared Jul 03, 2013
IFUSION
K130656
Optovue, Inc.
Ophthalmic · 113d
Cleared Jun 05, 2013
TRC-50DX RETINAL CAMERA
K123101
Topcon Medical Systems, Inc.
Ophthalmic · 244d
Cleared May 10, 2013
TRC-NW8 NON-MYDRIATIC RETINAL CAMERA
K130289
Topcon Corp.
Ophthalmic · 94d