# K250307: Visualase V2 MRI-guided Laser Ablation System (9736422)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation
- Decided: May 29, 2025 after 115 days
- Product code: ONO (Neurosurgical Laser With Mr Thermography)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K983831 (1999). 42 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211269: Visualase MRI-Guided Laser Ablation System (SW 3.4), Medtronic Navigation, Inc. (2022) Summary page 6.
- K240877: Monteris Medical NeuroBlate System, Monteris Medical, (2024) Summary page 6.

## Most influential descendants
- K253391: Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) (2026), 0 descendants of its own

## Indications for use
The Visualase V2 ™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.

Source page: https://510kreport.com/device/K250307
Methodology: https://510kreport.com/methodology