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The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 50 % in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No. 4.

The Lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.

The document provided describes the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device, K132854. The submission focuses on non-clinical testing to demonstrate safety and effectiveness.

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1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens" are established by demonstrating equivalence to the predicate device, "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854)." Performance is shown through comparative testing against the predicate's established characteristics.

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