Company ยท US
Kowa Optimed, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2002. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 11, 2002 | K013805 | KOWA AUTOMATED TONOMETER KT-500 Kowa Optimed, Inc. | HKX |
| Jun 17, 1996 | K961090 | AUTOMATIC VISUAL FIELD PLOTTER AP-125 Kowa Optimed, Inc. | HPT |
| Jun 4, 1996 | K960924 | KOWA HAND-HELD APPLANATION TONOMETER HA-1 Kowa Optimed, Inc. | HKY |
| Jan 3, 1996 | K955442 | KOWA SC-1200 PHOTO SLIT LAMP SYSTEM Kowa Optimed, Inc. | HKI |
| Dec 1, 1995 | K954781 | KOWA GENESIS HAND-HELD FUNDUS CAMERA Kowa Optimed, Inc. | HKI |
| Dec 1, 1995 | K954780 | KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C Kowa Optimed, Inc. | HKI |
| Nov 24, 1995 | K954782 | KOWA PORTABLE SLIT LAMP SL-14 & SL-14B Kowa Optimed, Inc. | HJO |
| Feb 7, 1992 | K913852 | LASER FLARE METER Kowa Optimed, Inc. | HJO |
| Sep 27, 1988 | K880920 | LASER FLARE CELL METER FC-1000 Kowa Optimed, Inc. | HJO |
| May 3, 1988 | K881219 | AUTOMATIC PERIMETER, AP-340 Kowa Optimed, Inc. | HPT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2020 | Kowa Optimed Inc Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s Terminated |
NFJ | K190056 |