510(k) · Cleared
ClearedLaser Thermal Therapy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elesta S.P.A · GEX Powered Laser Surgical Instrument
Cleared on May 22, 2023 as substantially equivalent to K053087 (Biotex, Inc., 2006) after a 90-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- May 22, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963081 (1997). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK963081 Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for…Indigo Medical, Inc. · 1997
- 1 generation backK053087 Visualase Cooled Laser Applicator System, Laser Diffusing Fiber…Biotex, Inc. · 2006 · Recalled
- This deviceK230460 Laser Thermal Therapy KitElesta S.P.A · 2023
- Descendant · cites it directly · 0 of its ownK260632 Laser Thermal Therapy KitElesta S.P.A · 2026
Most influential descendants
Showing 1 of 1 · See all- K260632Laser Thermal Therapy KitElesta S.P.A · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963081 | Indigo Medical Model Idl 830 & Model Idl 830E Laser Systems for General… | Indigo Medical, Inc. | 1997 | — |
| −1 | K053087 | Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling… | Biotex, Inc. | 2006 | 5 |
| 0 (this device) | K230460 | Laser Thermal Therapy Kit | Elesta S.P.A | 2023 | — |
| +1 | K260632 | Laser Thermal Therapy Kit | Elesta S.P.A | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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.
Planning a device in GEX? 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? (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 |
|---|---|---|---|
| * | K053087 | Visualase Cooled Laser Applicator System, Laser Diffusing Fiber, Cooling Catheter SystemSummary page 6…Device name 510(k) Number BioTex Inc., US Visualase Laser fiber LDF K053087 Complete substantial equivalence information is provided in the Section XII of this submission. 6. Reference Device… | 2006 |
| † | K140470 | Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission… | 2014 |
| † | K213594 | Echolaser X4 | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260632 | Laser Thermal Therapy Kit | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 17.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K260632 (Elesta S.P.A, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K053087.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 LASER THERMAL THERAPY KIT used to direct laser energy to soft tissue, to necrotize or coagulate soft tissue through interstitial irradiation 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, plastic surgery, orthopedics, pulmonology, radiology, and urology, at a wavelength of 1064nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230460: Laser Thermal Therapy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230460
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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