# K080794: Polyvue 55 Single Vision, Toric and Multifocal Soft (Hydrophilic) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Polyvue Distribution, Inc.
- Decided: Dec 17, 2008 after 272 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: 1 generation back to K051095 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051095: 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Optical Connection, Inc. (2005) Summary page 2.

## Most influential descendants
- K142766: I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (2015), 0 descendants of its own

## Indications for use
1-55 Single Vision (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. 1-55 Toric (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters. 1-55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 Diopters that does not interfere with visual acuity. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide, disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement.

Source page: https://510kreport.com/device/K080794
Methodology: https://510kreport.com/methodology