Visualase Thermal Therapy System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K181859 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Visualase Thermal Therapy System is an MRI-guided laser ablation device designed for laser interstitial thermal therapy (LITT). It employs a laser catheter to deliver focused light energy for precise tissue ablation, monitored in real-time via MRI imaging, enabling minimally invasive treatment of targeted brain lesions.
This system is supplied as a reusable medical device and is intended for use in MRI-compatible surgical settings. It is cleared by the FDA under 510(k) classification (K181859) and is regulated under the Radiology advisory committee category. The device requires proper MRI safety compliance and is intended for single-patient use per procedure.
Frequently asked questions
What types of brain lesions can the Visualase Thermal Therapy System treat, and how does it work?
The Visualase Thermal Therapy System is designed for minimally invasive laser ablation of targeted brain lesions using MRI-guided laser interstitial thermal therapy (LITT). It delivers focused light energy via a laser catheter, precisely ablating tissue under real-time MRI monitoring. This approach allows for accurate treatment of lesions while minimizing invasiveness compared to traditional surgical methods.
Is the Visualase Thermal Therapy System reusable, and how is it intended to be used per procedure?
Yes, the Visualase Thermal Therapy System is supplied as a reusable medical device, but it is intended for single-patient use per procedure. This means the system can be reused across multiple procedures, but it must be properly cleaned, maintained, and validated for each new patient treatment to ensure safety and efficacy.
What special considerations must be taken for MRI compatibility when using this device?
The Visualase Thermal Therapy System is designed for use in MRI-compatible surgical settings, meaning it must comply with strict MRI safety protocols. Since it integrates with MRI imaging for real-time monitoring, all components must be non-ferromagnetic and non-interfering with the MRI environment to prevent imaging artifacts or patient safety risks.
How is the device cleared by the FDA, and what does that mean for clinicians?
The Visualase Thermal Therapy System is cleared by the FDA under a 510(k) classification (K181859), specifically as substantially equivalent to a predicate device. This means it has been reviewed by the FDA’s Radiology Advisory Committee (RA) and deemed safe and effective for its intended use—MRI-guided laser ablation of brain lesions—based on clinical and technical evidence. Clinicians can rely on this clearance as validation of its design and performance standards.
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: Visualase™ V2 MRI-Guided Laser Ablation System | Medtronic, MRI-Guided Laser Ablation for Brain Tumors | Medtronic, How Medtronic upgraded its Visualase neuro laser ablation system
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181859 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA 510(k) K181859 24 fields · synced Sep 19, 2026