HKS · Class I · 21 CFR 886.1660

FDA Product Code HKS: Prism, Gonioscopic

Leading manufacturers include Ocular Instruments, Inc., Sensor Medical Technology, LLC and Jedmed Instrument Co..

10
Total
10
Cleared
58d
Avg days
1983
Since

FDA 510(k) Cleared Prism, Gonioscopic Devices (Product Code HKS)

10 devices
1–10 of 10
Cleared Apr 29, 2014
FAMILY OF DISPOSABLE LENSES
K140368
Sensor Medical Technology, LLC
Ophthalmic · 74d
Cleared Apr 01, 1994
OSHER SURGICAL GONIO/POSTERIOR POLE LENS
K935302
Ocular Instruments, Inc.
Ophthalmic · 150d
Cleared Dec 18, 1989
TWO MIRROR GONIO LENS
K895846
Ocular Instruments, Inc.
Ophthalmic · 76d
Cleared May 23, 1989
MCINTYRE SURGICAL GONIOLENS
K890977
Ocular Instruments, Inc.
Ophthalmic · 85d
Cleared Aug 21, 1986
KARICKHOFF DIAGNOSTIC/LASER LENS
K862692
Ocular Instruments, Inc.
Ophthalmic · 37d
Cleared Aug 21, 1986
ABRAHAM IRIDECTOMY LENS (YAG LASER)
K862713
Ocular Instruments, Inc.
Ophthalmic · 36d
Cleared Jul 11, 1986
SUSSMAN FOUR MIRROR HAND HELD GONIOPRISM
K862024
Ocular Instruments, Inc.
Ophthalmic · 44d
Cleared Jul 11, 1986
RITCH TRABECULOPLASTY LASER LENS
K862512
Ocular Instruments, Inc.
Ophthalmic · 10d
Cleared May 06, 1986
KETA HAND-HELD TONOMETER
K861027
Keta Corp.
Ophthalmic · 49d
Cleared Feb 07, 1983
DORC ADJUSTABLE IMAGE CONTACTS
K830169
Jedmed Instrument Co.
Ophthalmic · 20d

About Product Code HKS - Regulatory Context