# K133565: Leksell Gamma Knife Perfexion

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Instrument AB
- Decided: May 9, 2014 after 170 days
- Product code: IWB (System, Radiation Therapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K924849 (1995). 5 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120811: Leksell Gamma Knife Perfexion, Elekta Instrument AB (2012) Summary page 1.

## Most influential descendants
- K151159: Leksell Gamma Knife Perfexion (2015), 4 descendants of its own
- K151561: Leksell Gamma Knife Icon (2015), 4 descendants of its own
- K160440: Leksell Gamma Knife Icon (2016), 3 descendants of its own
- K173789: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon (2018), 2 descendants of its own
- K222047: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) (2022), 1 descendant of its own

## Indications for use
Leksell Gamma Knife® Perfexion™ 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, arteriovenous malformations, trigeminal neuralgia, medically refractory essential tremor, meningiomas, vestibular schwannomas, post-surgical pituitary adenomas and recurrent glioblastomas.

Source page: https://510kreport.com/device/K133565
Methodology: https://510kreport.com/methodology