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Kowa Optimed Inc

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0636-2021Class IIKowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX RetinaNovember 3, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K013805KOWA AUTOMATED TONOMETER KT-500October 11, 2002
K961090AUTOMATIC VISUAL FIELD PLOTTER AP-125June 17, 1996
K960924KOWA HAND-HELD APPLANATION TONOMETER HA-1June 4, 1996
K955442KOWA SC-1200 PHOTO SLIT LAMP SYSTEMJanuary 3, 1996
K954780KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500CDecember 1, 1995
K954781KOWA GENESIS HAND-HELD FUNDUS CAMERADecember 1, 1995
K954782KOWA PORTABLE SLIT LAMP SL-14 & SL-14BNovember 24, 1995
K913852LASER FLARE METERFebruary 7, 1992
K880920LASER FLARE CELL METER FC-1000September 27, 1988
K881219AUTOMATIC PERIMETER, AP-340May 3, 1988