ClearanceBrief
510(k) K090126 ยท GEX Powered Laser Surgical Instrument

FOTONA XP ND: YAG LASER SYSTEM FAMILY, FOTONA XP, XP-2 FOCUS, FOTONA XP CHANGER,MODEL MOO1-14F, MOO1-14F, MOO1-14F/2,

ApplicantFotona D.D., Ljubljana, SI
DecisionSubstantially Equivalent, Jun 29, 2009
ReceivedJan 21, 2009
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K090126

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.