510(k) · Cleared
Recalled · Class II · 2018Visualase Thermal Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotex, Inc. · LLZ System, Image Processing, Radiological
Cleared on Sep 10, 2008 as substantially equivalent to K071328 (Biotex, Inc., 2007) after a 90-day review. Its family tree reaches back 4 generations to 1991. 10 later devices descend from it. It has been recalled once.
- Decided
- Sep 10, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K913475 (1991). 11 ancestors in all. 10 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 3 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 2 generations backK063505 Visualase Envision Software SystemBiotex, Inc. · 2006
- 1 generation backK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
- This deviceK081656 Visualase Thermal Therapy SystemBiotex, Inc. · 2008
- Descendant · cites it directly · 9 of its ownK181859 Visualase Thermal Therapy SystemMedtronic Navigation, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 7 of its ownK214125 TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB · 2022
- Descendant · 2 generations on · 7 of its ownK211269 Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · Recalled
- Descendant · 3 generations on · 6 of its ownK231061 NeuroBlate SystemMonteris Medical, · 2023
- Descendant · 4 generations on · 5 of its ownK240877 Monteris Medical NeuroBlate SystemMonteris Medical, · 2024
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K181859Visualase Thermal Therapy SystemMedtronic Navigation, Inc. · 2019 · cites it directly9descendants
- K214125TRANBERG Thermoguide Therapy SystemClinical Laserthermia Systems, AB · 2022 · 2 generations on7descendants
- K211269Visualase MRI-Guided Laser Ablation System (SW 3.4)Medtronic Navigation, Inc. · 2022 · 2 generations on7descendants
- K231061NeuroBlate SystemMonteris Medical, · 2023 · 3 generations on6descendants
- K240877Monteris Medical NeuroBlate SystemMonteris Medical, · 2024 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −3 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −2 | K063505 | Visualase Envision Software System | Biotex, Inc. | 2006 | — |
| −1 | K071328 | Visualase Thermal Therapy System | Biotex, Inc. | 2007 | 1 |
| 0 (this device) | K081656 | Visualase Thermal Therapy System | Biotex, Inc. | 2008 | — |
| +1 | K181859 | Visualase Thermal Therapy System | Medtronic Navigation, Inc. | 2019 | 1 |
| +2 | K214125 | TRANBERG Thermoguide Therapy System | Clinical Laserthermia Systems, AB | 2022 | — |
| +2 | K211269 | Visualase MRI-Guided Laser Ablation System (SW 3.4) | Medtronic Navigation, Inc. | 2022 | 1 |
| +3 | K231061 | NeuroBlate System | Monteris Medical, | 2023 | — |
| +4 | K240877 | Monteris Medical NeuroBlate System | Monteris Medical, | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 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.
Planning a device in LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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…21CFR878.4810 (GEX) 21 CFR880.5725 (FRN) Predicate Devices Visualase Thermal Therapy System, K071328. Visualase Thermal Therapy System 510(k) Submission Page 13 of 132 Description of Device T… | 2007 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181859 | Visualase Thermal Therapy System | 2019 | 9 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2018 | Class II | Z-3251-2018 | Under Investigation by firm | Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in unaccounted spread of thermal energy to the surrounding tissue. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K181859 (Medtronic Navigation, Inc., 2019) has gone furthest, with 9 descendants of its own.
- 1 other device also cites its predicate K071328.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
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…
Read the full statement (206 words)
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, orthopedics, 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 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 Visualase Thermal Therapy System is compatible with General Electric Medical Systems Signa model MR scanners and with Siemens Medical Solutions Magnetom Espree systems. 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081656 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081656: Visualase Thermal Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081656
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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