510(k) · Cleared
ClearedEcholaser X4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En Electronic Engineering Spa · GEX Powered Laser Surgical Instrument
Cleared on Sep 4, 2018 as substantially equivalent to K080959 (Dornier Medtech America, Inc., 2008) after an 88-day review. Its family tree reaches back 12 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 4, 2018
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K943450 (1995). 143 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK063828 Diomed Delta 25Diomed, Ltd. · 2007
- 1 generation backK080959 Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc. · 2008
- This deviceK181510 Echolaser X4El.En Electronic Engineering Spa · 2018
- Descendant · cites it directly · 1 of its ownK213594 Echolaser X4Elesta S.P.A · 2022
- Descendant · 2 generations on · 0 of its ownK261964 Echolaser X4Elesta S.P.A · 2026
- Descendant · cites it directly · 0 of its ownK260632 Laser Thermal Therapy KitElesta S.P.A · 2026
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 4 generations backK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- 3 generations backK051996 Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd. · 2005
- 2 generations backK063828 Diomed Delta 25Diomed, Ltd. · 2007
- 1 generation backK080959 Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc. · 2008
- This deviceK181510 Echolaser X4El.En Electronic Engineering Spa · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −4 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| −3 | K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | Diomed, Ltd. | 2005 | — |
| −2 | K063828 | Diomed Delta 25 | Diomed, Ltd. | 2007 | — |
| −1 | K080959 | Dornier Medilas D 30 Laser, Medilas D 1064 | Dornier Medtech America, Inc. | 2008 | — |
| 0 (this device) | K181510 | Echolaser X4 | El.En Electronic Engineering Spa | 2018 | — |
| +1 | K213594 | Echolaser X4 | Elesta S.P.A | 2022 | — |
| +2 | K261964 | Echolaser X4 | Elesta S.P.A | 2026 | — |
| +1 | K260632 | Laser Thermal Therapy Kit | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K080959 | Dornier Medilas D 30 Laser, Medilas D 1064Summary page 4…trument for use in General and Plastic Surgery and in Dermatology (GEX) Classification Number: 21 CFR 878.4810 Equivalent Devices: DORNIER MEDILAS D 1064 laser system (K080959). Device Description: The ECHOLASER X4 is a medical device equipped with a diode laser source emitting at 1064nm wavelength in C… | 2008 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 143 ancestors have a recall of any class.
- Of its descendants, K213594 (Elesta S.P.A, 2022) has gone furthest, with 1 descendant 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. 2018, 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 intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), and in the treatment and/or removal of vascular lesions (tumors).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181510: Echolaser X4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181510
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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