ClearanceBrief
510(k) K252052 · HQC Unit, Phacofragmentation

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

ApplicantBausch and Lomb, Incorporated, St. Louis MO, US
DecisionSubstantially Equivalent, Mar 25, 2026
ReceivedJul 1, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K252052

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.