ClearanceBrief
510(k) K220516 ยท OOE Ophthalmic Femtosecond Laser

CATALYS Precision Laser system

ApplicantAmo Manufacturing USA, LLC, Milpitas CA, US
DecisionSubstantially Equivalent, May 17, 2022
ReceivedFeb 23, 2022
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K220516

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.