# K971134: Vista Eyeshower

- Pathway: 510(k) (Traditional)
- Applicant: John Branch
- Decided: Nov 4, 1997 after 221 days
- Product code: LXQ (Cup, Eye)
- Device class: U
- 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 Vista EYESHOWER is a single-use, disposable device intended for use with Irigate, sterile, isotonic, buffered eye wash (Optopics Laboratories Corp., Fairton, N.J.), supplied in a 1-ounce Boston round bottle for irrigating the eye to help relieve discomfort caused by foreign material, air pollutants, or chlorinated water.

Source page: https://510kreport.com/device/K971134
Methodology: https://510kreport.com/methodology