# K142851: CVue ADVANCED (hioxifilcon D) Soft (hydrophilic) Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Unilens Corp., USA
- Decided: Oct 30, 2014 after 30 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).
- (no number) LifeStyle MV2 Toric (polymacon) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K082853: Clinical Oxygen Dose Recorder (Codr), Model 300-CR, Inspired Technologies, Inc. (2009). Our reading of the summary gave K082853, FDA’s number for Clinical Oxygen Dose Recorder (Codr), Model 300-CR (Inspired Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for…”. Kept off the family tree. Summary page 6.

## Indications for use
The CVUE ADVANCED (hioxifilcon D) Single Vision 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 nondiseased 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 notaphakic 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/K142851
Methodology: https://510kreport.com/methodology