# K040303: 59% Extreme H2O (Hioxifilcon a) Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Hydrogel Vision Corporation
- Decided: Feb 2, 2005 after 359 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 K992692 (1999). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992692: Extreme H20 (Hioxifilicon a) Soft Contact Lens, Benz Research and Development Corp. (1999) Summary page 1.

## Most influential descendants
- K201268: Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (2020), 3 descendants of its own
- K222885: Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (2023), 2 descendants of its own
- K232649: Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (2024), 1 descendant of its own
- K251095: Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (2025), 0 descendants of its own
- K200618: HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens (2020), 0 descendants of its own

## Indications for use
The 59% Extreme H 2 0 (hioxifilcon A) toric soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 10.00 Diopters or less. Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K040303
Methodology: https://510kreport.com/methodology