# Kowa Co., Ltd.

- Location (FDA's records): Chuo-Ku, Tokyo, JP
- FDA decisions: 19 (2005–2022): 19 510(k) clearances
- Names in FDA's records: Kowa Co. , Ltd. (16); Kowa Company , Ltd. (3)
- Product codes: HKI (14), HJO (3), MYC (1), HKX (1)
- Predicates its devices cite: 18 (9 its own); citations of its devices by later devices: 23 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kowa Optimed, Inc.: 4 (https://510kreport.com/company/kowa-optimed)
- Nidek, Inc.: 2 (https://510kreport.com/company/nidek)
- Canon USA, Inc.: 1 (https://510kreport.com/company/canon-usa)
- Tearscience, Inc.: 1 (https://510kreport.com/company/tearscience)
- Canon Components, Inc.: 1 (https://510kreport.com/company/canon-components)

## Firms that cite its devices most
- Topcon Corporation: 2 (https://510kreport.com/company/topcon)
- Optomed OY: 2 (https://510kreport.com/company/optomed)
- Eyequick.Llc: 1 (https://510kreport.com/company/eyequick)
- Medimaging Integrated Solution, Inc (Miis): 1 (https://510kreport.com/company/medimaging-integrated-solution-miis)
- Optomed Oyj: 1 (https://510kreport.com/company/optomed-oyj)
- Kowa Co. Ltd. Chofu: 1 (https://510kreport.com/company/kowa-co-chofu)
- Centervue S.P.A.: 1 (https://510kreport.com/company/centervue)
- Optina Diagnostics, Inc.: 1 (https://510kreport.com/company/optina-diagnostics)

## Its most-cited devices
- K063640: Kowa SL-15 (2006), cited by 3
- K080681: Kowa Genesis-D (2008), cited by 3
- K043213: Kowa VX-10 (2005), cited by 2
- K053026: Kowa Nonmyd 7, Kowa Nonmyd a-D (2005), cited by 2
- K101628: Kowa Nonmyd WX (2011), cited by 2
- K050271: Kowa Genesis-D Hand-Held Retinal Camera (2005), cited by 2

## Recent decisions
- K222372: Kowa SL-19 (Nov 21, 2022)
- K191945: KOWA nonmyd 8 (Sep 10, 2019)
- K190573: KOWA DR-1a (Jun 4, 2019)
- K133755: Kowa SL-17 (Mar 11, 2014)
- K112330: Kowa VX-20 (Feb 16, 2012)
- K101628: Kowa Nonmyd WX (Jan 26, 2011)
- K091098: Kowagenesis-DF (Aug 7, 2009)
- K091039: Kowa, FM-600, Model LSS50 (Aug 7, 2009)

Source page: https://510kreport.com/company/kowa