# K963013: Preference 60 and Preference 60 Toric

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Dec 19, 1997 after 507 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- 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 Envoy and Envoy Toric (epsifilcon A) Contact Lenses are indicated for daily wear by non-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lenses may be worn by persons who exhibit astigmatism of 2.50 diopters or less, the toric lens by persons with astigmatism of 9.00 diopters.

Source page: https://510kreport.com/device/K963013
Methodology: https://510kreport.com/methodology