# K041608: C-Vue 55 Toric (Methafilcon a) Multifocal Contact Lens

- Pathway: 510(k) (Special)
- Applicant: Unilens Corp., USA
- Decided: Jul 7, 2004 after 22 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) LifeStyle MV2TM Toric (polymacon) Soft (hydrophilic) Multifocal Contact Lens: named in the summary without a submission number

## Most influential descendants
- 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-Vue55 Toric Multifocal Contact Lens is 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. Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K041608
Methodology: https://510kreport.com/methodology