ClearanceBrief
510(k) K250553 ยท OBO Tomography, Optical Coherence

Tomey Cornea/Anterior Segment OCT (CASIA2)

ApplicantTomey Corporation, Nagoya, JP
DecisionSubstantially Equivalent, Jul 18, 2025
ReceivedFeb 25, 2025
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K250553

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.