510(k) · Cleared
ClearedSLT Diffuser Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgical Laser Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 7, 2001 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 40 devices in its family, counting itself, have a Class I recall. 39 later devices descend from it.
- Decided
- Mar 7, 2001
- Review
- 61 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 3 citing it directly. 2 of the 40 devices in this family, counting this one, have a Class I recall.
- This deviceK010041 SLT Diffuser FiberSurgical Laser Technologies, Inc. · 2001
- Descendant · cites it directly · 33 of its ownK053087 Visualase Cooled Laser Applicator System, Laser Diffusing Fiber…Biotex, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 26 of its ownK071328 Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 22 of its ownK081509 Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009
- Descendant · 4 generations on · 21 of its ownK120561 Neuroblate SystemMonteris Medical, Inc. · 2013 · Recalled
- Descendant · 5 generations on · 19 of its ownK131955 Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · Recalled
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 39 · See all- K053087Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemBiotex, Inc. · 2006 · cites it directly33descendants
- K071328Visualase Thermal Therapy SystemBiotex, Inc. · 2007 · 2 generations on26descendants
- K081509Monteris Medical Autolitt Laser ProbeMonteris Medical, · 2009 · 3 generations on22descendants
- K120561Neuroblate SystemMonteris Medical, Inc. · 2013 · 4 generations on21descendants
- K131955Neuroblate (TM) SystemMonteris Medical, Inc. · 2013 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010041 | SLT Diffuser Fiber | Surgical Laser Technologies, Inc. | 2001 | — |
| +1 | K053087 | Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling… | Biotex, Inc. | 2006 | 5 |
| +2 | K071328 | Visualase Thermal Therapy System | Biotex, Inc. | 2007 | 1 |
| +3 | K081509 | Monteris Medical Autolitt Laser Probe | Monteris Medical, | 2009 | — |
| +4 | K120561 | Neuroblate System | Monteris Medical, Inc. | 2013 | 1 |
| +5 | K131955 | Neuroblate (TM) System | Monteris Medical, Inc. | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 1 |
| 2016 | 2 | 0 |
| 2017 | 5 | 1 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (39)
See all 393 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?
- Of its descendants, K053087 (Biotex, Inc., 2006) has gone furthest, with 33 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.
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 | — |
https://510kreport.com/device/K010041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010041: SLT Diffuser Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010041
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026