510(k) K252188

EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy) by Elekta Solutions AB — Product Code IYE

K252188 is an FDA 510(k) premarket notification submitted by Elekta Solutions AB for the device "EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)". The FDA issued a decision of Substantially Equivalent on January 15, 2026. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050. Elekta Solutions AB has at least 10 other 510(k) clearances on record.