# K100456: Cvue Advanced Definitive

- Pathway: 510(k) (Traditional)
- Applicant: Unilens Corp., USA
- Decided: Oct 28, 2010 after 253 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: 6 generations back to P810005 (1981). 19 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100221: INTELLIWAVE3, Art Optical Contact Lens, Inc. (2010). Cleared while this submission was under review Summary page 2.
- K082393: Cvue Advanced (Hioxifilcon D) Soft (Hydrophilic) Contact Lens, Unilens Corp., USA (2008) Summary page 2.
- K052560: Biofinity (Comfilcon a) Soft Contact Lens, CooperVision, Inc. (2005) Summary page 2.
- K983637: Actifresh 400 Lens, Hydron, Ltd. (1999) Summary page 2.

## Most influential descendants
- 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 C*VUE Advanced Definitive, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The C*VUE Advanced Definitive, torie (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 10 diopters. The C*VUE Advanced Definitive, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to ±4.00 diopters. The C*VUE Advanced Definitive, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wea are indicated for the correction of ametropia (myopia and hyperopia) in aphakic; and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to ±4.00 diopters. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K100456
Methodology: https://510kreport.com/methodology