# K081656: Visualase Thermal Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Sep 10, 2008 after 90 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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: 4 generations back to K913475 (1991). 11 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071328: Visualase Thermal Therapy System, Biotex, Inc. (2007) Summary page 1.

## Most influential descendants
- K181859: Visualase Thermal Therapy System (2019), 9 descendants of its own
- K214125: TRANBERG Thermoguide Therapy System (2022), 7 descendants of its own
- K211269: Visualase MRI-Guided Laser Ablation System (SW 3.4) (2022), 7 descendants of its own
- K231061: NeuroBlate System (2023), 6 descendants of its own
- K240877: Monteris Medical NeuroBlate System (2024), 5 descendants of its own

## Recalls of this device
- Jun 1, 2018 · Class II · Z-3251-2018: Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tiss

## Indications for use
The Visualase Thermal Therapy System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under magnetic resonance imaging (MRI) guidance in medicine and surgery in cardiovascular thoracic surgery (excluding the heart and the vessels in the pericardial sac), dermatology, ear-nose-throat surgery, gastroenterology, general surgery, gynecology, head and neck surgery, neurosurgery, plastic surgery, orthopedics, pulmonology, radiology, and urology, for wavelengths 800nm through 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Visualase system can process images using proton resonance-frequency (PRF) shift analysis and image subtraction to relate changes in complex phase angle back to relative changes in tissue temperature during therapy. The image data may be manipulated and viewed in a number of different ways, and the values of data at certain selected points may be monitored and/or displayed over time. The Visualase Thermal Therapy System is compatible with General Electric Medical Systems Signa model MR scanners and with Siemens Medical Solutions Magnetom Espree systems. When interpreted by a trained physician, this device provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of Visualase analysis.

Source page: https://510kreport.com/device/K081656
Methodology: https://510kreport.com/methodology