HJI · Class I · 21 CFR 886.1395

FDA Product Code HJI: Lens, Fundus, Hruby, Diagnostic

Leading manufacturers include Cooper Medical Devices Corp., Richard'S Medical Equip., Inc. and Optical Micro Systems, Inc..

8
Total
8
Cleared
62d
Avg days
1976
Since

FDA 510(k) Cleared Lens, Fundus, Hruby, Diagnostic Devices (Product Code HJI)

8 devices
1–8 of 8
Cleared Nov 16, 1992
BYRNE EXPULSIVE LENS
K923670
Ocular Instruments, Inc.
Ophthalmic · 117d
Cleared Jul 05, 1990
60 FUNDUS CAMERA CF-60UV
K901839
Canon USA, Inc.
Ophthalmic · 72d
Cleared Jul 05, 1990
STRIPE PROJECTOR
K902138
Academic Catalyst Corp.
Ophthalmic · 56d
Cleared Mar 12, 1990
LASER IMAGING WORK STATION
K897186
Innovision Medical, Inc.
Ophthalmic · 74d
Cleared Feb 05, 1982
OMS QUARTZ INFUSION CONTACT LENS
K820223
Optical Micro Systems, Inc.
Ophthalmic · 9d
Cleared Feb 05, 1981
SEBESTYEN IRRIGATING CONTACT LENS
K802927
Cooper Medical Devices Corp.
Ophthalmic · 78d
Cleared Feb 05, 1981
LANDERS CONTACT LENS
K802971
Cooper Medical Devices Corp.
Ophthalmic · 76d
Cleared Nov 11, 1976
CHARLES IRRIGATING FUNDUS CONTACT LENS
K760949
Richard'S Medical Equip., Inc.
Ophthalmic · 10d

About Product Code HJI - Regulatory Context