# K973756: Eye Sys Vista

- Pathway: 510(k) (Traditional)
- Applicant: Eyesys Technologies, Inc.
- Decided: Nov 13, 1997 after 42 days
- Product code: HLQ (Keratoscope, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.1350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The EyeSys Vista has the same intended use as other corneal Analysis and Topography Systems. It specifically measures, records and displays corneal curvature in a non-invasive manner. The EyeSys Vista will be operated by doctors and technicians in ophthalmic and optometric offices. Corneal topography analysis has become the standard of care for patient screening, pre and post operative corneal surgery documentation, corneal pathology determination and follow-up, as well as assisting in the fitting and follow-up of contact lenses.

Source page: https://510kreport.com/device/K973756
Methodology: https://510kreport.com/methodology