# K253391: Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Mar 13, 2026 after 164 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: 21 generations back to K983831 (1999). 43 ancestors in all.
No later device cites it as a predicate yet.
2 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K250307: Visualase V2 MRI-guided Laser Ablation System (9736422), Medtronic Navigation (2025) Summary page 5.
- K211269: Visualase MRI-Guided Laser Ablation System (SW 3.4), Medtronic Navigation, Inc. (2022) Summary page 5.

## Indications for use
The Visualase™ 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 medicine and surgery in the discipline of neurosurgery with 800nm through 1064nm lasers. 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/K253391
Methodology: https://510kreport.com/methodology