# K024003: Gelflex Delta Soft Contact Lens Material Methafilcon a 55% Water Content Clear or Blue Visitint, Gelflex Alpha Soft Cont

- Pathway: 510(k) (Traditional)
- Applicant: Gelflex
- Decided: Feb 5, 2003 after 63 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 Gelflex Delta (methafilcon A) Soft Contact Lenses in clear or blue visitint are indicated for daily wear in aphakic and non-aphakic persons with non-diseased eyes. The Gelflex Delta (methafilcon A) Spherical Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Delta (methafilcon A) Toric Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of up to 6.00 diopters. The Gelflex Delta (methafilcon A) Translating Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Delta (methafilcon A) Translating Toric Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of up to 6.00 diopters. The Gelflex Alpha (polymacon) Soft Contact Lenses in clear or blue visitint are indicated for daily wear in aphakic and non-aphakic persons with non-diseased eyes. The Gelflex Alpha (polymacon) Spherical Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Alpha (po1ymacon)Toric Soft Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) with astigmatism of up to 6.00 diopters. The Gelflex Alpha (polymacon) Translating Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of 0.5 diopters or less which does not interfere with visual acuity. The Gelflex Alpha (polymacon) Translating Toric Bifocal Lens is indicated for the correction of distance and near vision in presbyopic persons with astigmatism of up to 6.00 diopters. The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The Gelflex Delta (methafilcon A) Soft Contact Lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your eye care practitioner. The Gelflex Alpha (polymacon) Soft Contact Lenses may be disinfected using heat, chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your eye care practitioner.

Source page: https://510kreport.com/device/K024003
Methodology: https://510kreport.com/methodology