HKI · Class II · 21 CFR 886.1120

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

Leading manufacturers include Forus Health Pvt.Ltd, Optina Diagnostics, Inc. and Kowa Company , Ltd..

156
Total
156
Cleared
122d
Avg days
1977
Since
156 devices
25–48 of 156
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