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FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are indication for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes. The FreshLook® spherical and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.

FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity. The FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses also act to enhance or alter the apparent color of the eye.

The FreshLook® (nelfilcon A) One Day Color Contact Lenses are to be prescribed for single-use Daily Disposable Wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single-use.

FreshLook® (nelfilcon A) Soft (hydrophilic) One Day Color Contact Lenses are available in a spherical lens design, FreshLook® Progressives (nelfilcon A) One Day Color Contact Lenses are available in a multifocal lens design and FreshLook® Toric (nelfilcon A) One Day Color Contact Lenses are available in a toric design. The lenses are to be prescribed for single use daily disposable wear.

The FreshLook®, FreshLook® Toric and FreshLook® Progressives (nelfilcon A) One-Day Colors Contact Lens are daily wear soft contact lenses intended for single use daily disposable wear. The FreshLook One-Day Colors contact lens is a spherical soft contact, FreshLook One-Day Colors Toric lenses have a double thin zone design, and the FreshLook One-Day Colors Progressives lens is a progressive aspheric simultaneous vision soft contact lens. A constant near power profile is incorporated into each Progressive lens across the full range of distance powers. The near and intermediate powers are concentrated primarily in the central portion of the optical zone while the surrounding portion is weighted toward distance. The continuous changes in power across the surface of the lens allow patients requiring a reading addition of up to +3.00 diopters to see clearly at far, intermediate and near distances.

The lens material is 69% water and 31% nelfilcon A polymer (polyvinyl alcohol partially acetalized with N-formylmethyl acrylamide). The lenses are clear or tinted from edge to edge for visibility purposes with the color additive copper phthalocyanine (CuP). FreshLook® (nelfilcon A) One Day Color Contact Lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, [phthalocyaninato (2-)] copper, chromium oxide and carbazole violet.

Lenses are supplied sterile in foil sealed blister packs containing isotonic phosphate-acetate buffered saline solution. The package storage saline may contain up to 0.02% Poloxamer 108.

The physical properties of the lenses are:
Refractive Index: 1.38 (hydrated)
Center Thickness: 0.09 to 0.17 mm (0.10 at -3.00D; 0.15 at +3.00D) (varies with power)
Light Transmittance: Clear ≥ 97%, Visitint 96% (approx)
Oxygen Permeability (Dk): 26 x 10-11 (cm2/sec) (ml O2/ml x mm Hg) at 35° C (Fatt corrected)
Water Content: 69% by weight in normal saline

The provided text describes specific details about FreshLook® contact lenses and compares them to predicate devices. It does not contain information about acceptance criteria for a study, nor does it detail a study that proves the device meets such criteria.

Instead, the document is a 510(k) Summary of Safety and Effectiveness, which compares FreshLook® (nelfilcon A) One Day Color Soft Contact Lenses to previously cleared predicate devices to establish substantial equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving their fulfillment. The document explicitly states:

• "It was determined that Clinical Studies were not necessary to establish the safety it was dotemined the FreshLook® One Day Color (nelfilcon A) Soft Contact Lenses." (Page 4)

This indicates that a clinical study with specific performance metrics and acceptance criteria was not conducted or deemed necessary for this 510(k) submission. The equivalence was based on physical/chemical properties and manufacturing processes compared to predicate devices.

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