# K992692: Extreme H20 (Hioxifilicon a) Soft Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Benz Research and Development Corp.
- Decided: Oct 18, 1999 after 68 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.
32 later devices descend from it; 6 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Benz Research and Development Benz Lens “lathe cut” version: named in the summary without a submission number

## Most influential descendants
- K051430: Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric) (2005), 22 descendants of its own
- 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
- K052290: Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens (2006), 5 descendants of its own

## Indications for use
The 59% extreme H₂O® (hioxifilcon A) soft contact lens for daily wear are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of .75 Diopters or less that does not interfere with visual acuity. The lens are available clear and with a blue visibility handling tint. Eyecare 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 either a heat or chemical disinfection system.

Source page: https://510kreport.com/device/K992692
Methodology: https://510kreport.com/methodology