HKI · Class II · 21 CFR 886.1120

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

Leading manufacturers include Phelcom Technologies, Crystalvue Medical Corporation and Forus Health Pvt.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