# K031774: Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Westcon Contact Lens Co., Inc.
- Decided: Feb 20, 2004 after 256 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
Longest line of descent: 2 generations back to K954524 (1996). 3 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992010: W-55 (Methafilcon a) Clear and Visibility Tinted Lens Blank and Horizon 55 Soft (Clear) and Horizon 55 Westint (Tinted), Westcon Contact Lens Co., Inc. (1999) Summary page 2.
- K963837: Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut From Lens Blan, Westcon Contact Lens Co., Inc. (1996) Summary page 2.

## Most influential descendants
- K043540: Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses (2005), 4 descendants of its own
- K070308: Flexlens Multifocal Soft Contact Lens, (Hioxifilcon a) and (Hioxifilcon B) for Daily Wear (2007), 2 descendants of its own
- K100443: Definitive, Flexlens - Silicone Hydrogel (2010), 1 descendant of its own
- K242059: Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) (2024), 0 descendants of its own
- K080686: Westcon Horizon 49% (Hioxifilcon B) (2008), 0 descendants of its own

## Indications for use
Horizon 55 (methafilcon A), Horizon 55 (methafilcon A) soft Toric, Horizon 55 (methafilcon A) Bi-con, Horizon 55 (methafilcon A) Bi-con Toric, Horizon (methafilcon A) Progressive, Horizon (methafilcon A) Progressive Toric, Horizon 55 (methafilcon A) Westint (spherical), Horizon 55 (methafilcon A) Westint soft Toric, Horizon 55 (methafilcon A) Westint Bi-con, Horizon 55 (methafilcon A) Westint Bi-con Toric, Horizon (methafilcon A) Westint Progressive, Horizon (methafilcon A) Westint Progressive Toric are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic or not-aphakic persons with nondiseased eyes. The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The lenses may be disinfected using chemical systems only. The Horizon 38 (polymacon), Horizon 38 (polymacon) Westint, Westhin 38 Soft Toric (polymacon) and Westhin 38 Soft Toric Westint (polymacon) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopic, astigmatism) in aphakic or not-aphakic persons with nondiseased eyes. The color-enhanced version is indicated for daily wear to enhance or alter the apparent eye color. The color-enhanced lenses can be chemically disinfected only. The clear lenses may be disinfected using a heat or chemical disinfecting system.

Source page: https://510kreport.com/device/K031774
Methodology: https://510kreport.com/methodology