# K051095: 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Optical Connection, Inc.
- Decided: Aug 16, 2005 after 110 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.
20 later devices descend from it; 6 cite it directly.
0 of 21 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) Saview 55 F (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens: named in the summary without a submission number
- (no number) Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens: named in the summary without a submission number
- (no number) Saview 55 Toric Contact Lens: named in the summary without a submission number
- (no number) Frequency 55UV (methafilcon A) Soft (Hydrophilic) lenses: named in the summary without a submission number

## Most influential descendants
- K090806: Safi-Gel Daily Disposable (Methafilcon a) Soft (Hydrophilic) Contact Lens, Safi-Gel Daily Disposable Toric ( Methafilcon (2009), 12 descendants of its own
- K121201: Savie-Aqua 55UV (Methafilcon a) Tinnted Blue Soft (Hydrophilic) Contact Lens (2012), 11 descendants of its own
- K162317: Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens (2016), 7 descendants of its own
- K200296: Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (2020), 4 descendants of its own
- K092852: Saview 58 UV; Toric & Multifocal (Etafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear (2010), 3 descendants of its own

## Indications for use
The 55 UV (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. The 55 UV 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 and 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 55 UV 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/or not aphakic persons with non-diseased eyes. The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Source page: https://510kreport.com/device/K051095
Methodology: https://510kreport.com/methodology