# K051430: Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric)

- Pathway: 510(k) (Traditional)
- Applicant: Hydrogel Vision Corporation
- Decided: Jul 18, 2005 after 47 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.
22 later devices descend from it; 4 cite it directly.
0 of 24 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
- K153766: Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (2016), 12 descendants of its own
- K213119: Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (2022), 7 descendants of its own
- K062854: Benz-G 4X Hioxifilcon D (2007), 7 descendants of its own
- K082393: Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens (2008), 3 descendants of its own
- K222885: Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (2023), 2 descendants of its own

## Indications for use
The Extreme H 2 0® 54% (hioxifilcon D) 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 spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10.00 Diopters. 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/K051430
Methodology: https://510kreport.com/methodology