# Kowa Optimed, Inc.

- Location (FDA's records): Washington, DC
- FDA decisions: 10 (1988–2002): 10 510(k) clearances
- Product codes: HKI (3), HJO (3), HPT (2), HKY (1), HKX (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 8 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Kowa Co., Ltd.: 4 (https://510kreport.com/company/kowa)
- Optical Imaging, Ltd.: 1 (https://510kreport.com/company/optical-imaging)
- Visx, Incorporated: 1 (https://510kreport.com/company/visx)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Marcher Enterprises, Ltd.: 1 (https://510kreport.com/company/marcher-enterprises)

## Its most-cited devices
- K954780: Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C (1995), cited by 3
- K954782: Kowa Portable Slit Lamp SL-14 & SL-14B (1995), cited by 2
- K955442: Kowa SC-1200 Photo Slit Lamp System (1996), cited by 1
- K913852: Laser Flare Meter (1992), cited by 1
- K880920: Laser Flare Cell Meter FC-1000 (1988), cited by 1

## Recent decisions
- K013805: Kowa Automated Tonometer KT-500 (Oct 11, 2002)
- K961090: Automatic Visual Field Plotter AP-125 (Jun 17, 1996)
- K960924: Kowa Hand-Held Applanation Tonometer HA-1 (Jun 4, 1996)
- K955442: Kowa SC-1200 Photo Slit Lamp System (Jan 3, 1996)
- K954780: Kowa Professional Fundus Camera Models FX-500, FX-500S, FX-500C (Dec 1, 1995)
- K954781: Kowa Genesis Hand-Held Fundus Camera (Dec 1, 1995)
- K954782: Kowa Portable Slit Lamp SL-14 & SL-14B (Nov 24, 1995)
- K913852: Laser Flare Meter (Feb 7, 1992)

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