# K991781: Fluorex Ultra (Flusilfocon E) Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: G.T. Laboratories, Inc.
- Decided: Jun 29, 1999 after 35 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- 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)
- P880001: Fluorex (TM) 600 (Flursilfocon a), G.T. Laboratories, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P880001/S001 (Nov 10, 1988). Summary page 1.

## Indications for use
The Fluorex® Ultra (flusilfocon E) Spherical Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic, hyperopic and which may exhibit astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The Fluorex® Ultra (flusilfocon E) Translating Bifocal and Trifocal Contact Lenses are indicated for daily wear for the correction of visual acuity in not-aphakic persons with non-diseased presbyopic eyes that are myopic or hyperopic and which may exhibit astigmatism of 3.50 diopters or less that does not interfere with visual acuity.

Source page: https://510kreport.com/device/K991781
Methodology: https://510kreport.com/methodology