510(k) · Cleared
Recalled · Class II · 2022Evlt Kit and the D15PLUS and D30PLUS Diode Lasers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diomed, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 1, 2004 as substantially equivalent to K023543 (Diomed, Inc., 2002) and 2 other predicates after a 133-day review. Its family tree reaches back 8 generations to 1995. 297 later devices descend from it. It has been recalled once.
- Decided
- Dec 1, 2004
- Review
- 133 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K943450 (1995). 26 ancestors in all, the oldest K800617 (1980). 297 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 1 generation backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- This deviceK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004
- Descendant · cites it directly · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
- Descendant · 2 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · cites it directly · 132 of its ownK062822 Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 3 generations on · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
Showing 5 of 297 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 297 · See all- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · cites it directly263descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 2 generations on192descendants
- K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc. · 2006 · cites it directly132descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
- K081352Profile Multi-Platform SystemSciton, Inc · 2008 · 3 generations on112descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −1 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| 0 (this device) | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | — |
| +1 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
| +2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +1 | K062822 | Vari-Lase Endovenous Laser Console, Model 7500 | Vascular Solutions, Inc. | 2006 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +3 | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 12 | 0 |
| 2009 | 4 | 0 |
| 2010 | 10 | 0 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 10 | 0 |
| 2014 | 10 | 0 |
| 2015 | 14 | 0 |
| 2016 | 13 | 0 |
| 2017 | 11 | 0 |
| 2018 | 15 | 0 |
| 2019 | 10 | 0 |
| 2020 | 19 | 0 |
| 2021 | 13 | 0 |
| 2022 | 25 | 0 |
| 2023 | 17 | 0 |
| 2024 | 29 | 0 |
| 2025 | 44 | 0 |
| 2026 | 22 | 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? (3)
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 |
|---|---|---|---|
| * | K023543 | Evlt Kit and D15PLUS and D30PLUS DiodeSummary page 1…icate Devices The EVLT Kit and the DI 5Plus and D30Plus Lasers are substantially equivalent to the Diomned EVLT Kit and DIS5Plus and D3OPlus Diode Lasers (K023543), the Diomed 8 10 nm Surgical Lasers and EVLT Procedure Kit (KO 12398) and the Diomned ISPlus and Diomned 3OPlus La… | 2002 |
| * | K012398 | Diomed 15 Diode Laser | 2002 |
| * | K013499 | Diomed 15 Plus and Diomed 30PLUS LasersSummary page 1…and D3OPlus Diode Lasers (K023543), the Diomed 8 10 nm Surgical Lasers and EVLT Procedure Kit (KO 12398) and the Diomned ISPlus and Diomned 3OPlus Lasers (K0 13499). 4. Device Description The DIOM ED 15 Plus is a diode laser capable of delivering up to 1 19 i/cm 2 Of pulse… | 2001 |
What descends from it? (297)
See all 2974 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2022 | Class II | Z-1819-2022 | Under Investigation by firm | OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within the sheath. A damaged… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K072034 (Quanta System Spa, 2007) has gone furthest, with 263 descendants of its own.
- 7 other devices also cite its predicate K023543.
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 | — |
What is it indicated for?
The 810nm Diomed Laser and EVLT Procedure Kit are intended for use in the treatment of superficial vein reflux of the greater saphenous vein associated with varicosities. The Diomed D15 plus and D30 plus and EVLT Kits are indicated for treatment of incompetence and reflux of superficial veins in the lower extremity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041957 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041957: Evlt Kit and the D15PLUS and D30PLUS Diode Lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041957
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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