510(k) · Cleared
ClearedVisualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Navigation, Inc. · ONO Neurosurgical Laser With Mr Thermography
Cleared on Mar 13, 2026 as substantially equivalent to K250307 (Medtronic Navigation, 2025) and 1 other predicate after a 164-day review. Its family tree reaches back 21 generations to 1999. 2 of the 44 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 13, 2026
- Review
- 164 days
- Class
- Class II
- Product code
- ONO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 21 generations to K983831 (1999). 43 ancestors in all, the oldest K913475 (1991). No later device cites it as a predicate yet. 2 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 21 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 17 generations between
- 3 generations backK231061 NeuroBlate SystemMonteris Medical, · 2023
- 2 generations backK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
- 1 generation backK250307 Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation · 2025
- This deviceK253391 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled…Medtronic Navigation, Inc. · 2026
Show all 21 generations
- Root · 21 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 20 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 19 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 18 generations backK062086 NavivisionBrainlab AG · 2006
- 17 generations backK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- 16 generations backK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 15 generations backK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- 14 generations backK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- 13 generations backK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
- 12 generations backK162762 NeuroBlate SystemMonteris Medical, Inc. · 2016
- 11 generations backK170724 NeuroBlate SystemMonteris Medical, · 2017
- 10 generations backK171255 Monteris Medical NeuroBlate SystemMonteris Medical, Inc. · 2017 · Recalled (Class I)
- 9 generations backK172881 NeuroBlate SystemMonteris Medical, · 2017
- 8 generations backK173305 NeuroBlate SystemMonteris Medical, · 2017
- 7 generations backK182036 NeuroBlate SystemMonteris Medical, · 2018
- 6 generations backK193375 NeuroBlate SystemMonteris Medical, · 2020
- 5 generations backK201056 NeuroBlate SystemMonteris Medical, Inc. · 2020
- 4 generations backK211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · Recalled
- 3 generations backK231061 NeuroBlate SystemMonteris Medical, · 2023
- 2 generations backK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
- 1 generation backK250307 Visualase V2 MRI-guided Laser Ablation System (9736422)Medtronic Navigation · 2025
- This deviceK253391 Visualase Cooled Laser Applicator System (9735559); Visualase Cooled…Medtronic Navigation, Inc. · 2026
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −21 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −20 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −19 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −18 | K062086 | Navivision | Brainlab AG | 2006 | — |
| −17 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| −16 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −15 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| −14 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| −13 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
| −12 | K162762 | NeuroBlate System | Monteris Medical, Inc. | 2016 | — |
| −11 | K170724 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −10 | K171255 | Monteris Medical NeuroBlate System | Monteris Medical, Inc. | 2017 | Class I |
| −9 | K172881 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −8 | K173305 | NeuroBlate System | Monteris Medical, | 2017 | — |
| −7 | K182036 | NeuroBlate System | Monteris Medical, | 2018 | — |
| −6 | K193375 | NeuroBlate System | Monteris Medical, | 2020 | — |
| −5 | K201056 | NeuroBlate System | Monteris Medical, Inc. | 2020 | — |
| −4 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022 | 1 |
| −3 | K231061 | NeuroBlate System | Monteris Medical, | 2023 | — |
| −2 | K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024 | — |
| −1 | K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422) | Medtronic Navigation | 2025 | — |
| 0 (this device) | K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser… | Medtronic Navigation, Inc. | 2026 | — |
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 |
|---|---|---|---|
| * | K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422)Summary page 5…Ablation Systems - Visualase MRI-guided Laser Ablation System (V1 System, K211269) and Visualase V2 MRI-guided Laser Ablation System (V2 System, K250307). The V1 and V2 systems are not subjects of this submission. This change encompasses changes to the Vi… | 2025 |
| * | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4)Summary page 5…is an accessory to both cleared versions of the Visualase Cooled Laser Ablation Systems - Visualase MRI-guided Laser Ablation System (V1 System, K211269) and Visualase V2 MRI-guided Laser Ablation System (V2 System, K250307). The V1 and… | 2022 |
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 27 years and passes through 6 companies; a new generation was cleared every 12 months on median.
- 14 of the 43 ancestors have a recall of any class; 2 have a Class I recall.
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. 2026, 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 Visualase™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm…
Read the full statement (141 words)
The Visualase™ MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 800nm through 1064nm lasers.
The Visualase™ V2 MRI-Guided Laser Ablation System is a neurosurgical tool and is indicated for use to ablate, necrotize, or coagulate intracranial soft tissue including brain structures (for example, brain tumor, radiation necrosis, and epileptic foci as identified by non-invasive and invasive neurodiagnostic testing, including imaging) through interstitial irradiation or thermal therapy in pediatrics and adults with 980 nm lasers. The intended patients are adults and pediatric patients from the age of 2 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253391: Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253391
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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