ROCHESTER, N.Y. (USA), April 14, 2021
Acuity Polymers, a leading developer of innovative contact lens materials, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded indications of its ACUITY 200™ Ultra Dk daily wear gas permeable contact lenses [510(k) Number K203571].
ACUITY 200 contact lenses may now be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.
ACUITY 200 contact lenses are made from the newest generation contact lens material (fluoroxyfocon A) and feature the highest gas permeability of any contact lenses on the market. ACUITY 200 offers exceptional permeability and wettability for optimal ocular health protection, while providing excellent all-day wearing comfort. Available in spherical, aspheric, toric or multifocal designs as well as semi-scleral and scleral lenses.
“The FDA 510(k) clearance of ACUITY 200 for irregular corneal conditions provides specialty contact lens fitters with the highest Dk GP material to address the significant oxygen permeability needs of large diameter contact lens wearers” said Jim Bonafini, President of Acuity Polymers, Inc. “We’re excited to bring to market the first new GP material in ages, one that provides substantial benefits for patient eye health and wearing comfort.”
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