Monteris Medical, - FDA 510(k) Cleared Devices

Monteris Medical is a leader in minimally invasive laser ablation technology for the brain. The company develops and markets the NeuroBlate® System, a robotic, MR-guided laser interstitial thermal therapy (LITT) platform designed for neurosurgical applications. Monteris operates with a manufacturing facility in Alameda, US.

The company has received 12 FDA 510(k) clearances from 12 total submissions since its first clearance in 2009. Monteris specializes in neurology devices, with a focus on thermal ablation systems for brain tumors, radiation necrosis, and drug-resistant epilepsy. The company remains active, with its latest FDA 510(k) clearance in 2026.

The NeuroBlate System represents the company's core innovation: a cooled laser probe technology available in both diffuse (FullFire®) and directional (SideFire®) configurations. Supporting software, including NeuroBlate Fusion-S™, provides real-time MRI visualization and thermal monitoring during procedures. The platform serves adult and pediatric patients and is used across multiple neurosurgical indications.

Explore the complete regulatory history, device names, product codes, and clearance dates in the 510(k) database.

510(k) submissions have been managed by Monteris Medical as regulatory consultant.