# K963837: Horizon/Westhin 38 Sofblu (Polymacon) Soft (Spherical & Toric) Daily Wear Contact Lens (Tinted, Lathe-Cut From Lens Blan

- Pathway: 510(k) (Traditional)
- Applicant: Westcon Contact Lens Co., Inc.
- Decided: Dec 20, 1996 after 87 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.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K031774: Horizon (Methafilcon a) Daily Wear Sphere and Toric Contact Lenses (2004), 5 descendants of its own
- 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

Source page: https://510kreport.com/device/K963837
Methodology: https://510kreport.com/methodology