# K082393: Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Unilens Corp., USA
- Decided: Sep 11, 2008 after 23 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: 3 generations back to K992692 (1999). 3 ancestors in all.
3 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)
- K062854: Benz-G 4X Hioxifilcon D, Benz Research and Development Corp. (2007) Summary page 3.
- (no number) C-VUE® Toric Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens: named in the summary without a submission number

## Most influential descendants
- K100456: Cvue Advanced Definitive (2010), 2 descendants of its own
- K121652: Cvue Advanced Hydra Vue (2012), 0 descendants of its own
- K110452: Sof-Form II, Unilens, Unisite, Simulvue, Aquaflex, LL-38, Bayvue Aquaflex Mto, Unilens 38, Unisoft, Simulvue 38 Llbi 2, (2011), 0 descendants of its own

## Indications for use
The CVUE ADVANCED (hioxifilcon D) Single Vision and Multifocal Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity. The CVUE ADVANCED (hioxifilcon D)Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or not-aphakic persons with non-diseased eyes. 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/K082393
Methodology: https://510kreport.com/methodology