The FDA grants 510(k) clearance to LensAR's laser surgery system for a type of incision made during cataract surgeries.
The laser cataract surgery market has another player, now that the FDA's cleared its laser surgery device for another type of incision used during cataract surgery procedures.
LensAR said it won 510(k) clearance from the FDA for its laser cataract surgery device for arcuate incisions to the edge of the cornea.
The Orlando, Fla.-based medical device company said the regulatory watchdog's nod means the LensAR laser system is cleared in the U.S. for both corneal and arcuate incisions during cataract surgery and for anterior capsulotomy – an incision to open the capsule surrounding the eye's lens.
The LensAR Laser System is currently available for sale to cataract surgeons in the U.S., Europe and several other countries around the world.
"LensAR is deeply committed to providing cataract surgeons with the most advanced and sophisticated tools that support their delivery of optimal clinical outcomes to their patients. By adding arcuate incisions to our growing list of FDA cleared indications for the LensAR Laser System, we have further strengthened our position as the provider of the industry's most advanced, versatile, surgeon-and patient centric laser cataract system," CEO Nick Curtis said in prepared remarks. "Milestones of this type underpin the significant traction that we have experienced in rapidly accelerating the adoption of the LensAR platform among cataract surgeons around the world. We expect this latest development will only serve to further increase the growing demand for our system."
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