LENSAR, Inc. announced the application for certification of the ALLY Adaptive Cataract Treatment System “ALLY” or the “ALLY System” in the European Union. ALLY enables surgeons to complete a femtosecond-laser-assisted cataract surgery (“FLACS”) procedure seamlessly in a single, sterile environment and provide Adaptive Intelligence™ to automatically determine cataract density, optimize fragmentation patterns, and energy settings. The CE Mark, if affixed following successful completion of the certification process, allows for commercialization of ALLY in the European Union.

The application for certification in the European Union follows U.S. FDA clearance of ALLY in June 2022. If ALLY is certified and CE marked, LENSAR plans to make the system commercially available to European surgeons through a distributor network, similar to the approach taken for its first-generation LENSAR Laser System.