ORLANDO, Fla.—Lensar, Inc. (NASDAQ: LNSR), based here, announced that it has received U.S. Food and Drug Administration 510(k) clearance for its next-generation ALLY Adaptive Cataract Treatment System.
ALLY is the first FDA-cleared platform to enable cataract surgeons to complete the femtosecond-laser-assisted cataract surgery (FLACS) procedure seamlessly in a single, sterile environment, according to Lensar.
The company said it plans to deliver the first ALLY systems to surgeons in the third quarter of this year through a controlled and targeted initial launch.
Following this launch, Lensar plans to make ALLY widely available to cataract surgeons in 2023. Lensar CEO Nick Curtis said, “We are elated to bring this proprietary technology to cataract surgeons.
Our mission has been to develop a platform where surgeons can seamlessly perform the entire FLACS procedure in a single setting, improve workflow efficiencies, and most importantly, help surgeons deliver better outcomes through the advanced technologies in the ALLY system.
"We are seeing an overwhelmingly positive response to the ALLY system. Over 125 surgeons have experienced ALLY firsthand, during demonstrations performed at the American Society of Cataract and Refractive Surgery (ASCRS) annual meeting in April, and more recently at our home office,” Curtis said.