Cleared Traditional

Leksell Gamma Knife? (Elekta Esprit); Leksell Gamma Knife? (Icon?); Leksell Gamma Knife? (Perfexion?)

K250391 · Elekta Solutions AB · Radiology

Jul 2025

Decision

140d

Days

Class 2

Risk

About This 510(k) Submission

K250391 is an FDA 510(k) clearance for the Leksell Gamma Knife? (Elekta Esprit); Leksell Gamma Knife? (Icon?); Leksell Gamma Knife? (Perfexion?), a System, Radiation Therapy, Radionuclide (Class II — Special Controls, product code IWB), submitted by Elekta Solutions AB (Stockholm, SE). The FDA issued a Cleared decision on July 2, 2025, 140 days after receiving the submission on February 12, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5750.

Submission Details

510(k) Number	K250391 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2025
Decision Date	July 02, 2025
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF