510(k) · Cleared
Recalled · Class II · 2019Visualase Thermal Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotex, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Aug 31, 2007 as substantially equivalent to K063505 (Biotex, Inc., 2006) and 3 other predicates after a 112-day review. Its family tree reaches back 3 generations to 1991. 2 of the 37 devices in its family, counting itself, have a Class I recall. 26 later devices descend from it. It has been recalled once.
- Decided
- Aug 31, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 3 generations to K913475 (1991). 10 ancestors in all. 26 later devices descend from it, 2 citing it directly. 2 of the 37 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK913475 Magnetic Resonance Diagnostic DeviceGE Medical Systems · 1991
- 2 generations backK960265 Advantage Windows with Functool OptionGE Medical Systems · 1996 · Recalled
- 1 generation backK063505 Visualase Envision Software SystemBiotex, Inc. · 2006
- This deviceK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007
- Descendant · cites it directly · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- Descendant · 2 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 19 of its ownK131278 Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 18 of its ownK141983 Neuroblate SystemMonteris Medical Corp. · 2014 · Recalled
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 26 · See all- K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · cites it directly22descendants
- K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 2 generations on21descendants
- K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 3 generations on19descendants
- K131278Monteris Medical Neuroblate SystemMonteris Medical, Inc. · 2013 · 3 generations on19descendants
- K141983Neuroblate SystemMonteris Medical Corp. · 2014 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913475 | Magnetic Resonance Diagnostic Device | GE Medical Systems | 1991 | — |
| −2 | K960265 | Advantage Windows with Functool Option | GE Medical Systems | 1996 | 1 |
| −1 | K063505 | Visualase Envision Software System | Biotex, Inc. | 2006 | — |
| 0 (this device) | K071328 | Visualase Thermal Therapy System | Biotex, Inc. | 2007 | — |
| +1 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| +2 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +3 | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | 2 |
| +3 | K131278 | Monteris Medical Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +3 | K141983 | Neuroblate System | Monteris Medical Corp. | 2014 | 2 |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 1 | 0 |
| 2017 | 4 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K063505 | Visualase Envision Software SystemSummary page 1…21CFR878.4810 (GEX) 21CFRS8O.5725 (FRN) Predicate Devices Visualase ENVISION MRI Analysis Software by BioTex, Inc. K063505 PhoTexlis Surgical Diode Laser System by BioTex, Inc. K060304 Visualase Cooled Laser Applicator System… | 2006 |
| * | K060304 | Photex Diode Laser Series, Models 980, 810 and 940Summary page 1…) Predicate Devices Visualase ENVISION MRI Analysis Software by BioTex, Inc. K063505 PhoTexlis Surgical Diode Laser System by BioTex, Inc. K060304 Visualase Cooled Laser Applicator System by BioTex, Inc. K053087 K-pump by Kolster Methods, Inc. K991 2… | 2006 |
| * | K053087 | Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemSummary page 1…by BioTex, Inc. K063505 PhoTexlis Surgical Diode Laser System by BioTex, Inc. K060304 Visualase Cooled Laser Applicator System by BioTex, Inc. K053087 K-pump by Kolster Methods, Inc. K991 203 Description of Device The Visualase Thermal Therapy Syste… | 2006 |
| * | K991203 | Irrigation or Infusion Pump K PumpSummary page 1…cal Diode Laser System by BioTex, Inc. K060304 Visualase Cooled Laser Applicator System by BioTex, Inc. K053087 K-pump by Kolster Methods, Inc. K991 203 Description of Device The Visualase Thermal Therapy System comprises four devices: a laser energy source, a… | 1999 |
What descends from it? (26)
See all 262 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 8, 2019 | Class II | Z-1905-2020 | Nonconforming Material/Component | The firm received complaints on the saline tubing of Visualase Cooled Laser Applicator System (VCLAS) kit, including incorrect Luer connector assembly, incorrect drip-chamber assembly, and/or excessive adhesive causing tubing occlusion… |
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 16 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K081509 (Monteris Medical,, 2009) has gone furthest, with 22 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 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 (166 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, orthdfedics, 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 to determine 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.
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/K071328 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071328: Visualase Thermal Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071328
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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