regulatory
confidence high
sentiment positive
materiality 0.65
FDA accepts LENSAR's 510(k) for ALLY Adaptive Cataract Treatment System for substantive review
LENSAR, Inc.
- 510(k) submission for next-gen ALLY system accepted for substantive review by FDA.
- Company plans two-step release: additional 510(k) for phacoemulsification features later in 2022.
- Expects ALLY launch in H2 2022 if marketing clearance is granted.
- Conference call on March 3, 2022 to discuss Q4 and full year 2021 results.