# K251298: Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Laserthermia Systems, AB
- Decided: Sep 4, 2025 after 129 days
- Product code: ONO (Neurosurgical Laser With Mr Thermography)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K983831 (1999). 42 ancestors in all.
No later device cites it as a predicate yet.
2 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214125: TRANBERG Thermoguide Therapy System, Clinical Laserthermia Systems, AB (2022) Summary page 5.
- K240877: Monteris Medical NeuroBlate System, Monteris Medical, (2024) Summary page 5.

## Indications for use
The Thermoguide 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 neurosurgery for wavelengths of 1064nm. When therapy is performed under MRI guidance, and when data from compatible MRI sequences is available, the Thermoguide Therapy 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 Thermoguide Therapy System is compatible with 1.5T and 3.0T MR scanner systems: Siemens MRI Magnetom and GE MRI Signa. 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 analysis using the Thermoguide Therapy System

Source page: https://510kreport.com/device/K251298
Methodology: https://510kreport.com/methodology