# K023530: Horizon 38 (Clear) and Horizon 38 Westint (Tinted)

- Pathway: 510(k) (Traditional)
- Applicant: Westcon Contact Lens Co., Inc.
- Decided: Nov 26, 2002 after 36 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: 1 generation back to K963837 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Indications for use
The Horizon 38 (polymacon), Horizon 38 Westint (polymacon), 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 and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes. The lenses may be disinfected using either a heat or chemical system.

Source page: https://510kreport.com/device/K023530
Methodology: https://510kreport.com/methodology