LENSAR, Inc. (NASDAQ: LNSR) (“LENSAR” or “the Company”), a global medical technology company focused on advanced femtosecond laser surgical solutions for the treatment of cataracts, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted its 510(k) submission for its next-generation ALLY™ Adaptive Cataract Treatment System for substantive review. The submission seeks marketing clearance for the ALLY Adaptive Cataract Treatment System 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.
LENSAR Announces U.S. Food and Drug Administration Acceptance of 510(k) Submission for ALLY
Mar 01, 2022
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