# K020642: Soft K. and Soft K. Toric (Xyloficon a) Soft (Hydrophillic) Keratoconus Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Soflex Contact Lens Industries, Ltd.
- Decided: May 24, 2002 after 86 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 Soft K. (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system. The Soft K. Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.

Source page: https://510kreport.com/device/K020642
Methodology: https://510kreport.com/methodology