# K051184: 55 SV,  Multifocal and Toric (Ocufilcon C) Soft (Hydrophilic) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: United Contact Lens, Inc.
- Decided: Jul 1, 2005 after 53 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 K941607 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941607: Ucl Multifocal Soft Contact Lens, United Contact Lens, Inc. (1994) Summary page 2.

## Cited in the summary but kept off the family tree
- P920008: 55 F, Toric 55 and Multifocal (ocufilcon C) Soft (Hydrophilic) Contact Lenses. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The 55 SV (ocufilcon C) 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 Multifocal (ocufilcon C) 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 Toric (ocufilcon C) 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/K051184
Methodology: https://510kreport.com/methodology