510(k) · Cleared
ClearedMonteris Medical Autolitt Laser Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Monteris Medical, · GEX Powered Laser Surgical Instrument
Cleared on May 1, 2009 as substantially equivalent to K071328 (Biotex, Inc., 2007) and 2 other predicates after a 337-day review. Its family tree reaches back 4 generations to 1999. 2 of the 44 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it.
- Decided
- May 1, 2009
- Review
- 337 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K983831 (1999). 21 ancestors in all, the oldest K913475 (1991). 22 later devices descend from it, 3 citing it directly. 2 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK014256 Kolibri Igs SystemsBrainlab AG · 2002
- 2 generations backK042721 Kolibri SpineBrainlab AG · 2005
- 1 generation backK062086 NavivisionBrainlab AG · 2006
- This deviceK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- Descendant · cites it directly · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 18 of its ownK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
- Descendant · 3 generations on · 17 of its ownK143457 NeuroBlate SystemMonteris Medical, Inc. · 2015 · Recalled (Class I)
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · cites it directly21descendants
- K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 2 generations on19descendants
- K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · 2 generations on19descendants
- K141983Neuroblate SystemMonteris Medical Corp. · 2014 · 2 generations on18descendants
- K143457NeuroBlate SystemMonteris Medical, Inc. · 2015 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K014256 | Kolibri Igs Systems | Brainlab AG | 2002 | — |
| −2 | K042721 | Kolibri Spine | Brainlab AG | 2005 | — |
| −1 | K062086 | Navivision | Brainlab AG | 2006 | — |
| 0 (this device) | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| +1 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +2 | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | 2 |
| +2 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +2 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
| +3 | K143457 | NeuroBlate System | Monteris Medical, Inc. | 2015 | Class I |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 4 | 1 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K071328 | Visualase Thermal Therapy SystemSummary page 1…Thermal Therapy Laser Probe & Laser Stereotaxic instrument System Premarket Notification # K071328 K062719 K062086 Predicate Device 21CFR 878.4810 21CFR 878.4810 21 CF… | 2007 |
| * | K062719 | Greenlight HPS Series Surgical Laser System & AccessoriesSummary page 1…hermal Therapy Laser Probe & Laser Stereotaxic instrument System Premarket Notification # K071328 K062719 K062086 Predicate Device 21CFR 878.4810 21CFR 878.4810 21 CFR 882.4560 Classification:… | 2006 |
| * | K062086 | NavivisionSummary page 1…Laser Probe & Laser Stereotaxic instrument System Premarket Notification # K071328 K062719 K062086 Predicate Device 21CFR 878.4810 21CFR 878.4810 21 CFR 882.4560 Classification: Predicate Device Classi… | 2006 |
What descends from it? (22)
See all 223 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- 5 of the 21 ancestors have a recall of any class.
- Of its descendants, K120561 (Monteris Medical, Inc., 2013) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K071328.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Monteris Medical AutoLITT System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers. The Monteris Medical AutoLITT System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible…
Read the full statement (115 words)
The Monteris Medical AutoLITT System is indicated for use to
necrotize or coagulate soft tissue through interstitial irradiation or
thermal therapy in medicine and surgery in the discipline of
neurosurgery with 1064 nm lasers.
The Monteris Medical AutoLITT System is intended for planning
and monitoring thermal therapies under MRI visualization. It
provides MRI-based trajectory planning assistance for the
stereotaxic placement of MRI compatible (conditional) AutoLITT
Laser Delivery Probe. It also provides real-time thermographic
analysis of selected MRI images.
When interpreted by a trained physician, this System 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 the AutoLITT analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081509 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081509: Monteris Medical Autolitt Laser Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081509
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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