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NeuroBlate System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131955

by Monteris Medical Inc

Identifiers

510(k) Number
K131955 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NeuroBlate System is a robotic, MRI-guided laser ablation device designed for interstitial thermal therapy (LITT) in the brain. It is classified as a laser ablation system for neurosurgical applications, enabling precise, minimally invasive treatment of brain lesions, including tumors, radiation necrosis, and epilepsy foci. The device delivers focused laser energy under real-time MRI visualization to achieve targeted tissue ablation without the need for open neurosurgery. Its design integrates robotic guidance and thermal monitoring to enhance accuracy and safety during procedures.

The NeuroBlate System is supplied as a reusable medical device intended for use in sterile operating environments, such as neurosurgical suites equipped with MRI capabilities. It is regulated under FDA 510(k) clearance (K131955) and is classified under product code GEX for general plastic surgery applications. The system requires compatibility with MRI-compatible surgical settings and is intended for single-patient use per procedure. Storage and handling follow standard sterile medical device protocols to maintain device integrity and performance.

Frequently asked questions

What is the NeuroBlate System used for in neurosurgery?

The NeuroBlate System is designed for interstitial thermal therapy (LITT) in the brain, allowing minimally invasive treatment of brain lesions such as tumors, radiation necrosis, and epilepsy foci. It delivers focused laser energy under real-time MRI guidance, enabling targeted tissue ablation without traditional open neurosurgery. This approach enhances precision and reduces surgical risks by combining robotic guidance with thermal monitoring.

Is the NeuroBlate System reusable or single-use?

The NeuroBlate System is a reusable medical device, intended for use in sterile operating environments like neurosurgical suites equipped with MRI capabilities. It is designed for single-patient use per procedure, ensuring compliance with sterile protocols to maintain device integrity and performance during each application.

What storage and handling requirements does the NeuroBlate System have?

The NeuroBlate System must be stored and handled according to standard sterile medical device protocols to preserve its performance and functionality. Since it is reusable and intended for use in MRI-compatible surgical settings, proper cleaning, sterilization, and maintenance are critical. Follow manufacturer guidelines to ensure compatibility with MRI environments and to prevent contamination or damage between procedures.

Does the NeuroBlate System require compatibility with specific MRI settings?

Yes, the NeuroBlate System is specifically designed for use in MRI-compatible surgical environments. Its integration with MRI technology allows real-time visualization and guidance during laser ablation procedures. Ensure the operating room and MRI equipment meet the system’s requirements for safe and effective use, as outlined in the manufacturer’s instructions.

How does the NeuroBlate System enhance accuracy during neurosurgical procedures?

The NeuroBlate System combines robotic guidance with real-time MRI visualization to deliver precise, focused laser energy directly to targeted brain tissue. This dual approach minimizes collateral damage, reduces surgical risks, and allows clinicians to achieve controlled ablation of lesions—such as tumors or epilepsy foci—without the need for invasive open surgery. Thermal monitoring further ensures safety by enabling adjustments during the procedure.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NeuroBlate® System | Brain Laser Ablation | Monteris, NeuroBlate System Overview | LITT for Neurosurgeons - Monteris, NEUROBLATE(TM) SYSTEM (K131955) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monteris Medical Inc
FDA Applicant
Monteris Medical, Inc.

Sources (1)

  • FDA 510(k) K131955 24 fields · synced Oct 1, 2026