# K033655: Soflex Soft K (Xylofilcon a) Soft (Hydrophilic) Keratoconus Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Soflex Contact Lens Industries, Ltd.
- Decided: Jul 30, 2004 after 252 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 non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with visual acuity. 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 non-aphakic persons that exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism. The lens may be disinfected with a chemical or heat disinfection system.

Source page: https://510kreport.com/device/K033655
Methodology: https://510kreport.com/methodology