# K190573: KOWA DR-1a

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Company, Ltd.
- Decided: Jun 4, 2019 after 90 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K913929 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091935: Lipiview Ocular Surface Interferometer, Tearscience, Inc. (2009) Summary page 5.

## Indications for use
The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician in adult patients to observe and record a video image of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

Source page: https://510kreport.com/device/K190573
Methodology: https://510kreport.com/methodology