# K071328: Visualase Thermal Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Biotex, Inc.
- Decided: Aug 31, 2007 after 112 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 3 generations back to K913475 (1991). 10 ancestors in all.
26 later devices descend from it; 2 cite it directly.
2 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063505: Visualase Envision Software System, Biotex, Inc. (2006) Summary page 1.
- K060304: Photex Diode Laser Series, Models 980, 810 and 940, Biotex, Inc. (2006) Summary page 1.
- K053087: Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter System, Biotex, Inc. (2006) Summary page 1.
- K991203: Irrigation or Infusion Pump K Pump, Kmi Kolster Methods, Inc. (1999) Summary page 1.

## Most influential descendants
- K081509: Monteris Medical Autolitt Laser Probe (2009), 22 descendants of its own
- K120561: Neuroblate System (2013), 21 descendants of its own
- K131955: Neuroblate (TM) System (2013), 19 descendants of its own
- K131278: Monteris Medical Neuroblate System (2013), 19 descendants of its own
- K141983: Neuroblate System (2014), 18 descendants of its own

## Recalls of this device
- Jul 8, 2019 · Class II · Z-1905-2020: The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessiv

## 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, orthdfedics, 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 to determine 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. 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/K071328
Methodology: https://510kreport.com/methodology