Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

The Largan U38 Color (Polymacon) Daily Wear Soft Contact Lens is a daily wear soft contact lens made of polymacon (38% water, 62% polymer) indicated to correct myopia and hyperopia and to enhance or alter eye color. It can be prescribed for single-use disposable wear or frequent replacement wear with chemical disinfection only, for patients with non-diseased eyes and astigmatism of 1.00D or less.

The device is aspherical, cast-molded, with diameter 13.0–15.0 mm, base curve 8.0–9.0 mm, power –10.00D to +3.00D, center thickness 0.100 mm at –3.00D, refractive index 1.435, oxygen permeability 8.0 DK (Fatt method), and 90% light transmittance. It contains color additives (phthalocyanine green, carbazole violet, copper phthalocyaninato, titanium dioxide, iron oxides, mica-based pearlescent pigment) and uses benzophenone UV absorber for UVB/UVA blocking.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (ocular irritation and skin sensitization), and ISO 10993-11 (acute systemic toxicity). Testing followed FDA's 1994 Premarket Notification Guidance Document for Class II Daily Wear Contact Lenses.

The subject device is substantially equivalent to its primary predicate (K182674, Largan U38 Polymacon) because they share identical chemical composition (polymacon), lens design (aspherical), water content (38%), oxygen permeability (8.0 DK), base curve range, diameter, center thickness, power range, and manufacturing method (cast molded). The only differences are the addition of color additives for cosmetic enhancement and a light blue tint dye, which are FDA-approved (21 CFR 73 and 74) and do not alter the optical or biocompatibility performance. Biocompatibility testing confirms the colored lens is non-cytotoxic, non-irritating, and non-sensitizing.