Kowa Optimed Inc
FDA Regulatory Profile
Kowa Optimed Inc appears in FDA public data with 1 recall, 10 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0636-2021, Class II) was initiated on November 3, 2020. Its most recent 510(k) clearance was granted on October 11, 2002.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 10
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0636-2021 | Class II | Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retina | November 3, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K013805 | KOWA AUTOMATED TONOMETER KT-500 | October 11, 2002 |
| K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 | June 17, 1996 |
| K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 | June 4, 1996 |
| K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM | January 3, 1996 |
| K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA | December 1, 1995 |
| K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C | December 1, 1995 |
| K954782 | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B | November 24, 1995 |
| K913852 | LASER FLARE METER | February 7, 1992 |
| K880920 | LASER FLARE CELL METER FC-1000 | September 27, 1988 |
| K881219 | AUTOMATIC PERIMETER, AP-340 | May 3, 1988 |