Medical Device Manufacturer · US , Rockville , MD

Kowa Co. , Ltd. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2005

Recent clearances: KOWA SL-17, KOWA VX-20, KOWA NONMYD WX

View 16 510(k) Devices ↓

Total

Cleared

Denied

Kowa Co. , Ltd. has 16 FDA 510(k) cleared ophthalmic devices. Based in Rockville, US.

Historical record: 16 cleared submissions from 2005 to 2014.

Browse the complete list of FDA 510(k) cleared ophthalmic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Tuv Rheinland of North America, Inc. and Kowa Company , Ltd..

Kowa Co. , Ltd. is one of 18952 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Kowa Co. , Ltd.

16 devices

1-16 of 16

KOWA, FM-600, MODEL LSS50

MODIFICATION TO KOWA NONMYD ALPHA-DIII

K083387 · HKI

Ophthalmic · 60d

Cleared Oct 21, 2008

KOWA NONMYD ALPHA-DIII

KOWA NONMYD 7, KOWA NONMYD A-D

K053026 · HKI

Ophthalmic · 14d

Cleared Nov 03, 2005

KOWA GENESIS-D HAND-HELD RETINAL CAMERA

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 04, 2026

Kowa Co. , Ltd. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Kowa Co. , Ltd.

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