Lensar Submits FDA 510(k) Application for ALLY

Lensar announced that the FDA has accepted its 510(k) submission for its next-generation ALLY Adaptive Cataract Treatment System for review. The submission 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.

“FDA acceptance for substantive review of the 510(k) submission for ALLY marks an important milestone for Lensar and is the result of several years of diligent teamwork and focused effort on the part of our development team. 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, Chief Executive Officer of Lensar, said in a company news release. “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. We believe ALLY has the potential to improve surgeon efficiencies, including optimizing FLACS procedures in any operating room and enabling surgeons to deliver improved outcomes for patients. We look forward to the FDA’s review of the 510(k).”

Lensar expects to launch ALLY in the second half of 2022, if cleared.