510(k) · Cleared
ClearedEcholaser X4
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 3, 2022 as substantially equivalent to K181510 (El.En Electronic Engineering Spa, 2018) after a 172-day review. Its family tree reaches back 13 generations to 1995. 1 later device descends from it.
- Decided
- May 3, 2022
- Review
- 172 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K943450 (1995). 144 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK063828 Diomed Delta 25Diomed, Ltd. · 2007
- 2 generations backK080959 Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc. · 2008
- 1 generation backK181510 Echolaser X4El.En Electronic Engineering Spa · 2018
- This deviceK213594 Echolaser X4Elesta S.P.A · 2022
- Descendant · cites it directly · 0 of its ownK261964 Echolaser X4Elesta S.P.A · 2026
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 7 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 6 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 5 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 4 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 3 generations backK063828 Diomed Delta 25Diomed, Ltd. · 2007
- 2 generations backK080959 Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc. · 2008
- 1 generation backK181510 Echolaser X4El.En Electronic Engineering Spa · 2018
- This deviceK213594 Echolaser X4Elesta S.P.A · 2022
Most influential descendants
Showing 1 of 1 · See all- K261964Echolaser X4Elesta 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 |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −7 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −6 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −5 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −4 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| −3 | K063828 | Diomed Delta 25 | Diomed, Ltd. | 2007 | — |
| −2 | K080959 | Dornier Medilas D 30 Laser, Medilas D 1064 | Dornier Medtech America, Inc. | 2008 | — |
| −1 | K181510 | Echolaser X4 | El.En Electronic Engineering Spa | 2018 | — |
| 0 (this device) | K213594 | Echolaser X4 | Elesta S.P.A | 2022 | — |
| +1 | K261964 | Echolaser X4 | Elesta S.P.A | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 1 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 15 | 0 |
| 1997 | 19 | 0 |
| 1998 | 8 | 0 |
| 1999 | 5 | 0 |
| 2000 | 16 | 0 |
| 2001 | 15 | 0 |
| 2002 | 18 | 0 |
| 2003 | 3 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K181510 | Echolaser X4Summary page 4…. Predicate Devices Predicate Applicant Device name 510(k) Number Primary EL.EN. ELECTRONIC ECHOLASER X4 K181510 ENGINEERING SPA Reference Medtronic Navigation Visualase Thermal Therapy K181859… | 2018 |
| † | K181859 | Visualase Thermal Therapy System | 2019 |
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 |
|---|---|---|---|
| K261964 | Echolaser X4 | 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 27 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 144 ancestors have a recall of any class.
- Of its descendants, K261964 (Elesta S.P.A, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K181510.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 ECHOLASER X4 laser system is indicated for use 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 1064 nm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213594 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213594: Echolaser X4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213594
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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