Is this your brand? Sign in to claim ownership.
Sign in to claim this brandKowa Co. , Ltd.
US
Last updated May 23, 2026
What Kowa Co. , Ltd. makes
Kowa Co., Ltd. manufactures ophthalmic examination devices including slit lamps, fundus cameras, battery-operated tonometers, aqueous flare/cell measuring systems, and automatic perimeters. Specific products include the KOWA nonmyd series, FM-600, VX-10a, SL-19, and AP-7000.
The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510(k) and FDA UDI registries. Kowa Co., Ltd. is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Kowa Co., Ltd. manufacture?
Kowa Co., Ltd. manufactures ophthalmic examination devices including slit lamps, fundus cameras, battery-operated tonometers, aqueous flare/cell measuring systems, and automatic perimeters. Specific products include the KOWA nonmyd series, FM-600, VX-10a, SL-19, and AP-7000.
Where is Kowa Co., Ltd. based?
Kowa Co., Ltd. is based in the US. The company operates in the United States, where it manufactures and distributes its ophthalmic examination devices to healthcare professionals and institutions.
Which regulatory registries list Kowa Co., Ltd.'s devices?
Kowa Co., Ltd.'s devices are listed in the FDA 510(k) and FDA UDI registries. These registries track medical devices that have been notified to the FDA and have unique device identifiers for traceability purposes.
How are Kowa Co., Ltd.'s devices classified?
Kowa Co., Ltd.'s devices are classified under Class I and Class II by regulatory authorities. Class I devices are low-risk, while Class II devices require more regulatory controls to ensure their safety and effectiveness for ophthalmic examinations.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (50)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| KOWA nonmyd 8 | K9L61K | FDA UDI | Class II | Active |
| Kowa Fm-600 | LSS50BK | FDA UDI | Class II | Active |
| KOWA nonmyd a-DIII | K9L58K | FDA UDI | Class II | Active |
| KOWA nonmyd 7 | K9L39F9K | FDA UDI | Class II | Active |
| KOWA VX-10a | K9L48BK | FDA UDI | Class II | Active |
| Kowa Sl-19 | SL191K/W | FDA UDI | Class II | Active |
| KOWA VK-2s | VK28K | FDA UDI | Class II | Unknown |
| Kowa Ap-7000 | FT10K | FDA UDI | Class I | Active |
| Kowa Sl-17 | SL170K/P | FDA UDI | Class II | Active |
| Kowa Sl-17 | SL170K/W | FDA UDI | Class II | Active |
| KOWA VK-2s | VK28UE | FDA UDI | Class II | Unknown |
| KOWA VK-2s | VK28U2E | FDA UDI | Class II | Unknown |
| Kowa Sl-19 | SL191K/A | FDA UDI | Class II | Active |
| Kowa Sl-17 | SL170K/G | FDA UDI | Class II | Active |
| Kowa Sl-17 | SL170K/A | FDA UDI | Class II | Active |
| KOWA Applanation Tonometer HA-2 | ATO-6K | FDA UDI | Class II | Active |
| KOWA nonmyd AF | K9L64K | FDA UDI | Class II | Active |
| Kowa Sl-15 | SL150K | FDA UDI | Class II | Active |
| Kowa Vx-10 | K9L48K | FDA UDI | Class II | Active |
| Kowa Sl-19 | SL192BK/W | FDA UDI | Class II | Active |
| Kowa Sl-19 | SL191K/B | FDA UDI | Class II | Active |
| Kowa Sl-19 | SL191K/G | FDA UDI | Class II | Active |
| Kowa Genesis-D | K9L51K | FDA UDI | Class II | Active |
| KOWA GENESIS-Df | K9L51BK | FDA UDI | Class II | Active |
| KOWA nonmyd WX | K9L57FK | FDA UDI | Class II | Active |
| Kowa Sl-19 | SL191K/P | FDA UDI | Class II | Active |
| Kowa Sl-19 | SL191BK/W | FDA UDI | Class II | Active |
| Kowa Vx-20 | K9L56BK | FDA UDI | Class II | Active |
| Kowa Kt-800 | TO8K | FDA UDI | Class II | Active |
| KOWA nonmyd 8s | K9L63K | FDA UDI | Class II | Active |
| Kowa Dr-1α | DE2K | FDA UDI | Class II | Unknown |
| Kowa Vx-10i | K062021 | FDA 510(k) | Class II | Active |
| Kowa Nonmyd Alpha-D | K062356 | FDA 510(k) | Class II | Active |
| KOWA DR-1a | K190573 | FDA 510(k) | Class II | Active |
| Kowa Vx-10 | K043213 | FDA 510(k) | Class II | Active |
| Kowa Sl-17 | K133755 | FDA 510(k) | Class II | Active |
| Kowa Genesis-D Hand-Held Retinal Camera | K050271 | FDA 510(k) | Class II | Active |
| Kowa Vx-10 A | K091683 | FDA 510(k) | Class II | Active |
| Kowa, Fm-600, Model Lss50 | K091039 | FDA 510(k) | Class II | Active |
| Kowagenesis-Df | K091098 | FDA 510(k) | Class II | Active |
| Kowa SL-19 | K222372 | FDA 510(k) | Class II | Active |
| Kowa Nonmyd Alpha-Diii | K082767 | FDA 510(k) | Class II | Active |
| Kowa Vx-20 | K112330 | FDA 510(k) | Class II | Active |
| Kowa Genesis-D | K080681 | FDA 510(k) | Class II | Active |
| Kowa Nonmyd 7, Kowa Nonmyd A-D | K053026 | FDA 510(k) | Class II | Active |
| Modification To Kowa Nonmyd Alpha-Diii | K083387 | FDA 510(k) | Class II | Active |
| Kowa Nonmyd Wx | K101628 | FDA 510(k) | Class II | Active |
| KOWA nonmyd 8 | K191945 | FDA 510(k) | Class II | Active |
| Kowa Sl-15 | K063640 | FDA 510(k) | Class II | Active |
| Kowa Kt-800 | K053444 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.