ClearanceBrief
510(k) K191650 ยท HQC Unit, Phacofragmentation

LEGION System

ApplicantAlcon Research, LLC, Fort Worth TX, US
DecisionSubstantially Equivalent, Nov 1, 2019
ReceivedJun 20, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K191650

DateFirm and productCodeLinked 510(k)
Aug 16, 2023Alcon Research, LTD.
Legion FMS Pak
Open, Classified
HQCNone listed

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