ClearanceBrief
510(k) K250501 ยท HQC Unit, Phacofragmentation

System Sophi

ApplicantThis AG, Heerbrugg, CH
DecisionSubstantially Equivalent, Nov 14, 2025
ReceivedFeb 20, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250501

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.