# K250391: Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Jul 2, 2025 after 140 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K926449 (1995). 52 ancestors in all.
No later device cites it as a predicate yet.
0 of 53 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222047: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant), Elekta Solutions AB (2022) Summary page 5.

## Recalls of this device
- Feb 18, 2026 · Class II · Z-1581-2026: Due to adapter not being properly aligned or locked in place.

## Indications for use
Leksell Gamma Knife® is a teletherapy device intended for stereotactic irradiation of head structures ranging from very small target sizes of a few millimeters to several centimeters e.g. * Metastatic tumors * Recurrent glioblastomas * Trigeminal neuralgia * Medically refractory essential tremor * Orbital tumors * Ocular tumors * Optic nerve tumors * Benign diseases (such as meningiomas, vestibular schwannomas, post-surgical pituitary adenomas, craniopharyngioma, hemangioblastomas, schwannomas, arteriovenous malformations, cavernous malformations, chordomas, glomus tumors, hemangiomas) * Skull base tumors * Head and neck tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, oropharynx, nasopharynx, sinonasal, salivary gland) * Pediatric tumors (such as glioma, ependymoma, pituitary tumors, hemangioblastoma, craniopharyngioma, meningioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformations, cavernous malformations, skull base tumors) * Refractory mesial temporal lobe epilepsy in adults * Refractory epilepsy associated with structural changes such as hamartomas, cerebral cavernous malformations, and arteriovenous malformations (adult and pediatric)

Source page: https://510kreport.com/device/K250391
Methodology: https://510kreport.com/methodology