FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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 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 55 UV Toric (methafilcon A) Soft (Hydrophilic) Contact Lens 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. Then prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Device Description

The 55 UV, 55 UV Multifocal, and the 55 UV Toric (methafilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells, which cover the cornea and a portion of the adjacent sclera. The 55 UV Contact Lens is available in a single vision lens design, the 55 UV Toric Contact Lens is available in a double slab-off back surface design and the 55 UV Multifocal Contact Lens is available in an aspheric lens design. The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with ethyleneglycol dimethacrylate (45.0%) and water (55.0%). A UV absorbing compound, 2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny]] ethyl methacrylate, has been incorporated into the lens polymer. Lenses are tinted using the color additive Pigment Blue 15, ([Phthalocyaninato(2-)] copper).

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets these criteria. Instead, it is a 510(k) summary for contact lenses, primarily comparing the proposed devices to predicate devices to establish substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study as this information is not present in the input.

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K Number

K003526

Device Name

SPECIALTY 55 UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY 55 UV MULTIFOCAL (METHAFILCON)

Manufacturer

SPECIALTY ULTRAVISION, INC.

Date Cleared

2001-02-12

(88 days)