# K211269: Visualase MRI-Guided Laser Ablation System (SW 3.4)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Jan 7, 2022 after 255 days
- Product code: ONO (Neurosurgical Laser With Mr Thermography)
- Device class: 2
- Regulation: 21 CFR 878.4810
- 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: 17 generations back to K983831 (1999). 37 ancestors in all.
7 later devices descend from it; 3 cite it directly.
2 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201056: NeuroBlate System, Monteris Medical, Inc. (2020) Summary page 5.
- K181859: Visualase Thermal Therapy System, Medtronic Navigation, Inc. (2019) Summary page 5.

## Most influential descendants
- K231061: NeuroBlate System (2023), 6 descendants of its own
- K240877: Monteris Medical NeuroBlate System (2024), 5 descendants of its own
- K260976: NeuroBlate System (2026), 1 descendant of its own
- K250307: Visualase V2 MRI-guided Laser Ablation System (9736422) (2025), 1 descendant of its own
- K262315: NeuroBlate System (2026), 0 descendants of its own

## Recalls of this device
- Oct 14, 2022 · Class II · Z-0244-2023: Due to a defect in the outer pouch sterile seal

## 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.

Source page: https://510kreport.com/device/K211269
Methodology: https://510kreport.com/methodology