GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

The GPA (hexafocon A) Rigid Gas Permeable Contact Lenses are lathe-manufactured daily wear contact lenses made from a blue-tinted fluoro silicone acrylate material for correcting refractive errors (myopia, hyperopia, and astigmatism) in both aphakic and non-aphakic persons. Various designs are available including standard, toric, multifocal, and specialty designs for keratoconus and other irregular corneal conditions.

The GPA lenses use hexafocon A material (FDA Group #3 fluoro silicone acrylate) manufactured by lathe-cutting, with oxygen permeability of 100 × 10⁻¹¹ cm²/sec, refractive index of 1.415, and optional UV absorber. Multiple design configurations include aspherical, toric, and concentric multifocal surface patterns with parameter ranges matching or exceeding predicate devices.

ISO 10993-5 (in vitro cytotoxicity), ISO 10993-11 (systemic toxicity), ISO 10993-23 (acute ocular irritation), ANSI Z80.20 (finished product tolerances), and ISO 13485 (quality management system).

The GPA lenses are substantially equivalent to predicate devices (K000795 and K171404) based on identical intended use (daily wear), indication (refractive correction and therapeutic use for irregular cornea), classification (21 CFR 886.5916, Class II), material (hexafocon A), and manufacturing method (lathe-cut). Non-clinical biocompatibility and bioburden testing confirmed safety equivalent to predicates, and clinical studies were waived per FDA guidance for Class II daily wear contact lenses.