510(k) K250391

Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) by Elekta Solutions AB — Product Code IWB

K250391 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)". The FDA issued a decision of Substantially Equivalent on July 2, 2025. The device falls under product code IWB (System, Radiation Therapy, Radionuclide), a Class II device regulated under 21 CFR 892.5750. Elekta Solutions AB has at least 10 other 510(k) clearances on record.