The FDA accepted a 510(k) submission from LENSAR (NASDAQ:LNSR) for its next-generation ALLY Adaptive Cataract Treatment System for substantive review.
The submission seeks marketing clearance for the ALLY and is the first-stage of a planned, two-step commercial release strategy. As part of this strategy, the company plans to submit an additional 510(k) application seeking clearance for the phacoemulsification features within the integrated ALLY system later in 2022.
“We believe that, if ALLY is cleared by the FDA, this staged-approach would allow for an expeditious and efficient path to commercialization,” Nick Curtis, CEO of LENSAR, said in a statement. LENSAR expects to launch ALLY in the second half of 2022, if cleared.
He said the vast majority of cataract surgeons performing FLACS procedures rely on aging femtosecond lasers. ALLY’s design includes a small footprint, enhanced ergonomics, superior imaging, dual-pulsed laser, and advanced astigmatism management tools, which “we believe, if cleared, would set the new standard of femtosecond laser cataract technology,” he added.
FLACS uses a laser to create an incision in the cornea, open the cataract membrane or capsules, and then to soften the cataract prior to removal.
Mr. Curtis said ALLY has the potential to improve surgeon efficiencies, including optimizing FLACS procedures in any operating room, and to enable surgeons to deliver improved outcomes for patients.