# K080686: Westcon Horizon 49% (Hioxifilcon B)

- Pathway: 510(k) (Traditional)
- Applicant: Westcon Contact Lens Co.
- Decided: Apr 22, 2008 after 42 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: 4 generations back to K954524 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043540: Horizon 59 Oasis (Hioxifilcon a) Daily Wear Contact Lenses, Westcon Contact Lens Co., Inc. (2005) Summary page 1.
- K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint, Benz Research and Development Corp. (1997) Summary page 1.

## Indications for use
Horizon TM 49 (hioxifilcon B) Spherical, Horizon TM 49 (hioxifilcon B) Toric, HorizonTM 49 (hioxifilcon B) Bi-con, HorizonTM 49 (hioxifilcon B) Bi-con Toric, Horizon TM 49 (hioxifilcon B) Progressive, HorizonTM 49 (hioxifilcon B) Progressive Toric for daily wear are indicated for the correction of refractive ametropia (myopia, hyperopic, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be disinfected using chemical systems only.

Source page: https://510kreport.com/device/K080686
Methodology: https://510kreport.com/methodology