Kowa Optimed, Inc. - FDA 510(k) Cleared Devices
10
Total
10
Cleared
0
Denied
FDA 510(k) Regulatory Record - Kowa Optimed, Inc. Ophthalmic ✕
10 devices
Cleared
Oct 11, 2002
KOWA AUTOMATED TONOMETER KT-500
Ophthalmic
330d
Cleared
Jun 17, 1996
AUTOMATIC VISUAL FIELD PLOTTER AP-125
Ophthalmic
90d
Cleared
Jun 04, 1996
KOWA HAND-HELD APPLANATION TONOMETER HA-1
Ophthalmic
90d
Cleared
Jan 03, 1996
KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
Ophthalmic
36d
Cleared
Dec 01, 1995
KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
Ophthalmic
45d
Cleared
Dec 01, 1995
KOWA GENESIS HAND-HELD FUNDUS CAMERA
Ophthalmic
45d
Cleared
Nov 24, 1995
KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
Ophthalmic
38d
Cleared
Feb 07, 1992
LASER FLARE METER
Ophthalmic
164d
Cleared
Sep 27, 1988
LASER FLARE CELL METER FC-1000
Ophthalmic
207d
Cleared
May 03, 1988
AUTOMATIC PERIMETER, AP-340
Ophthalmic
42d