510(k) · Cleared
ClearedMobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Laserthermia Systems, AB · ONO Neurosurgical Laser With Mr Thermography
Cleared on Sep 4, 2025 as substantially equivalent to K214125 (Clinical Laserthermia Systems, AB, 2022) and 1 other predicate after a 129-day review. Its family tree reaches back 20 generations to 1999. 2 of the 43 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 4, 2025
- Review
- 129 days
- Class
- Class II
- Product code
- ONO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K983831 (1999). 42 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet. 2 of the 43 devices in this family, counting this one, have a Class I recall.
- Root · 20 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 16 generations between
- 3 generations backK211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · Recalled
- 2 generations backK231061 NeuroBlate SystemMonteris Medical, · 2023
- 1 generation backK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
- This deviceK251298 Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1)…Clinical Laserthermia Systems, AB · 2025
Show all 20 generations
- Root · 20 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 19 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 18 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 17 generations backK062086 NavivisionBrainlab AG · 2006
- 16 generations backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- 15 generations backK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 14 generations backK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 13 generations backK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- 12 generations backK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
- 11 generations backK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
- 10 generations backK170724 NeuroBlate SystemMonteris Medical, · 2017
- 9 generations backK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
- 8 generations backK172881 NeuroBlate SystemMonteris Medical, · 2017
- 7 generations backK173305 NeuroBlate SystemMonteris Medical, · 2017
- 6 generations backK182036 NeuroBlate SystemMonteris Medical, · 2018
- 5 generations backK193375 NeuroBlate SystemMonteris Medical, · 2020
- 4 generations backK201056 NeuroBlate SystemMonteris Medical, Inc. · 2020
- 3 generations backK211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · Recalled
- 2 generations backK231061 NeuroBlate SystemMonteris Medical, · 2023
- 1 generation backK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
- This deviceK251298 Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1)…Clinical Laserthermia Systems, AB · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −19 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −18 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −17 | K062086 | Navivision | Brainlab AG | 2006 | — |
| −16 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| −15 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −14 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −13 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| −12 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
| −11 | K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016 | — |
| −10 | K170724 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −9 | K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017 | Class I |
| −8 | K172881 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −7 | K173305 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −6 | K182036 | NeuroBlate System | Monteris Medical, | 2018 | — |
| −5 | K193375 | NeuroBlate System | Monteris Medical, | 2020 | — |
| −4 | K201056 | NeuroBlate System | Monteris Medical, Inc. | 2020 | — |
| −3 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022 | 1 |
| −2 | K231061 | NeuroBlate System | Monteris Medical, | 2023 | — |
| −1 | K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024 | — |
| 0 (this device) | K251298 | Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser… | Clinical Laserthermia Systems, AB | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ONO device
- #1 K240877 Monteris Medical NeuroBlate Systemscore 24.9 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K214125 | TRANBERG Thermoguide Therapy SystemSummary page 5…dicate Device Common Neurosurgical Laser with Neurosurgical Laser with MR Name: MR Thermography Thermography Predicate Device Premarket K214125 K240877 Notification Number: Predicate Device 21 CFR 878.4810; Laser 21 CFR 878.4810; Laser Cl… | 2022 |
| * | K240877 | Monteris Medical NeuroBlate SystemSummary page 5…rgical Laser with Neurosurgical Laser with MR Name: MR Thermography Thermography Predicate Device Premarket K214125 K240877 Notification Number: Predicate Device 21 CFR 878.4810; Laser 21 CFR 878.4810; Laser Classification s… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 26 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 42 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K214125.
How does its category compare?
All ONO devicesONO Neurosurgical Laser With Mr Thermography: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ONO
3so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · ONO
57in 2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ONO
1in 2017
MAUDE reports naming product code ONO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 0 |
| 2026 | 3 | 57 | 0 | — |
What is it indicated for?
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…
Read the full statement (174 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251298 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251298: Mobile Laser Unit (1001-N2); Thermoguide Workstation (1100-N1); Laser Applicator (4012-N5, 4017-N2, 4017-N4); MR Introducer (4013-N6).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251298
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026