# K033949: Varilux Visionprint System (VPS)

- Pathway: 510(k) (Traditional)
- Applicant: Essilor Intl.
- Decided: Jul 2, 2004 after 196 days
- Product code: HLL (Monitor, Eye Movement)
- Device class: 2
- Regulation: 21 CFR 886.1510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K902954 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K902954: OBER2 Monitor, Eye Movement (Ophthalmic), Permobil AB (1990) Summary page 1.

## Indications for use
The VPS is a non-invasive ultrasonic device intended to measure the pattern of eye and head movement when viewing lateral visual stimulus, to use as a guide for prescribing progressive power eyeglass lenses.

Source page: https://510kreport.com/device/K033949
Methodology: https://510kreport.com/methodology