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.”
About Acuity Polymers, Inc.:
The company is focused on providing the best of class materials for specialty vision products around the globe. Acuity Polymers is dedicated to creating new material solutions for protection of ocular health and vision. Acuity Polymers is an ISO 13485:2016 certified, privately held company, headquartered in Rochester, NY (USA) and has global distribution through a network of specialty lens manufacturers. For more information, visit acuitypolymers.com or contact the company directly at This email address is being protected from spambots. You need JavaScript enabled to view it..
