Lensar announces FDA clearance for ALLY Adaptive Cataract Treatment System
Lensar announced it has received U.S. Food and Drug Administration 510(k) clearance for its next-generation ALLY Adaptive Cataract Treatment System, according to a company press release.
This is the first FDA-cleared system enabling surgeons to complete femtosecond-laser-assisted cataract (FLACS) procedure surgery in a single, sterile environment.
A targeted initial launch of the system is scheduled for the third quarter of 2022, with a wider launch for cataract surgeons slotted for 2023.
“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 Annual Meeting in April, and more recently at our home office,” said Nick Curtis, Chief Executive Officer of Lensar in the press release.
Read the full press release here.