# K062854: Benz-G 4X Hioxifilcon D

- Pathway: 510(k) (Traditional)
- Applicant: Benz Research and Development Corp.
- Decided: Aug 6, 2007 after 315 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: 2 generations back to K992692 (1999). 2 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051430: Extreme H2O 54% (Hioxifilcon D) Soft Contact Lens (Spherical and Toric), Hydrogel Vision Corporation (2005) Summary page 2.

## Most influential descendants
- K082393: Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens (2008), 3 descendants of its own
- K100456: Cvue Advanced Definitive (2010), 2 descendants of its own
- K150590: CONTAFLEX 54 (hioxifilcon D) Spherical Soft Contact Lens for Daily Wear, CONTAFLEX 49 (hioxifilcon B) Spherical Soft Contact Lens for Daily Wear, (2015), 1 descendant of its own
- K153305: EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear (2016), 0 descendants of its own
- K121652: Cvue Advanced Hydra Vue (2012), 0 descendants of its own

## Indications for use
The Benz G 4X (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 prescribe for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K062854
Methodology: https://510kreport.com/methodology
