# K964702: Euclid Systems Corneal Topographer Model ET800

- Pathway: 510(k) (Traditional)
- Applicant: Euclid Systems Corp.
- Decided: May 20, 1997 after 176 days
- Product code: MMQ (Topographer, Corneal, 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
Indicated for use for measuring the shape and curvature of the anterior surface of the cornea of the eye and for displaying the topographical maps of the surface of the cornea. This information can be used to analyze, monitor and evaluate the shape and symmetry of the cornea following refractive surgery, to assist in the diagnosis of keratoconus, to assist in the fitting of contact lenses, to assist in the understanding of various corneal irregularities such as those induced by post operative sutures and wounds, and to assist in the understanding of various refractive conditions of the cornea, such as myopia, hyperopia, and astigmatism.

Source page: https://510kreport.com/device/K964702
Methodology: https://510kreport.com/methodology