Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

The Eye Secret 38 UV Aspheric and Air Light 38 UV Aspheric are soft contact lenses made of polymacon material for daily wear. They correct refractive errors (myopia or hyperopia) in people with non-diseased eyes and can be worn for frequent replacement or single-use disposable wear, with UV-blocking properties incorporated into the lens material.

The subject device uses polymacon material with 38% water content and aspheric lens design, with refractive index 1.440 ± 0.005 nd. It has oxygen permeability of 13.5 × 10⁻¹¹ cm²/sec and offers four packaging solution options (standard saline, sodium hyaluronate, PMB, or cyanocobalamin). The Eye Secret variant has center thickness 0.06–0.13 mm and powers from −20.00 to +20.00 D; Air Light variant is thinner (0.03 mm) with powers 0.00 to −10.00 D.

ISO 18369-4:2017 and ISO 18369-3:2017 for physiochemical properties and measurement methods; ISO 10993-5, ISO 10993-10, and ISO 10993-11 for cytotoxicity, ocular irritation, and acute systemic toxicity testing; also referenced FDA's 1994 Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses.

The subject device is substantially equivalent because it uses the same material composition (polymacon), manufacturing method (cast molding), sterilization process (moist heat autoclave), and packaging approach as the primary predicate (Eye Secret 38 UV K150630), with identical optical properties, water content, and intended use indications. The addition of four packaging solution options does not change the device's fundamental function or safety profile, as demonstrated by equivalent physiochemical and toxicology test results across all packaging variants.