Clearance Summary
Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) received FDA 510(k) clearance under submission number K250391, sponsored by Elekta Solutions AB. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2025-07-02.
- Submission: K250391
- Applicant / Sponsor: Elekta Solutions AB
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5750
- Decision date: 2025-07-02
Classification & Regulation
This clearance is catalogued under FDA product code IWB and 21 CFR 892.5750, within the Radiology review panel as a Class II device.