510(k) · Cleared
ClearedEvlt Kit and D15PLUS and D30PLUS Diode
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 2, 2002 after a 41-day review. The FDA summary names no predicate by number. 345 later devices descend from it.
- Decided
- Dec 2, 2002
- Review
- 41 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
345 later devices descend from it, 8 citing it directly.
- This deviceK023543 Evlt Kit and D15PLUS and D30PLUS DiodeDiomed, Inc. · 2002
- Descendant · cites it directly · 306 of its ownK040294 Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc. · 2004
- Descendant · cites it directly · 303 of its ownK042211 Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004
- Descendant · 2 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- Descendant · cites it directly · 297 of its ownK041957 Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 263 of its ownK072034 Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007
Showing 5 of 345 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 345 · See all- K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc. · 2004 · cites it directly306descendants
- K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc. · 2004 · cites it directly303descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 2 generations on299descendants
- K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc. · 2004 · cites it directly297descendants
- K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa · 2007 · 2 generations on263descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K023543 | Evlt Kit and D15PLUS and D30PLUS Diode | Diomed, Inc. | 2002 | — |
| +1 | K040294 | Laserpro Diode Laser Systems, Models 810, 940 & 980 | Photo Medex, Inc. | 2004 | — |
| +1 | K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems | Surgical Laser Technologies, Inc. | 2004 | — |
| +2 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| +1 | K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | Diomed, Inc. | 2004 | 1 |
| +2 | K072034 | Diode Medical Laser Family, Models 4, 6, 30 | Quanta System Spa | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 17 | 0 |
| 2009 | 8 | 0 |
| 2010 | 12 | 0 |
| 2011 | 7 | 0 |
| 2012 | 9 | 0 |
| 2013 | 12 | 0 |
| 2014 | 13 | 0 |
| 2015 | 14 | 0 |
| 2016 | 13 | 0 |
| 2017 | 13 | 0 |
| 2018 | 17 | 0 |
| 2019 | 14 | 0 |
| 2020 | 20 | 0 |
| 2021 | 13 | 0 |
| 2022 | 26 | 0 |
| 2023 | 17 | 0 |
| 2024 | 31 | 0 |
| 2025 | 47 | 0 |
| 2026 | 25 | 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?
The FDA summary names no predicate by number.
What descends from it? (345)
See all 3458 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040294 | Laserpro Diode Laser Systems, Models 810, 940 & 980 | 2004 | 306 |
| K042211 | Modification to: Laserpro 810, 940, and 980 Diode Diode Laser Systems | 2004 | 303 |
| K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | 2004 | 297 |
| K040921 | Cooltouch, Model NS 160 | 2004 | 204 |
| K033237 | Vascular Solutions Vari-Lase Endovenous Laser Console | 2003 | 133 |
| K062822 | Vari-Lase Endovenous Laser Console, Model 7500 | 2006 | 132 |
| K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | 2005 | 89 |
| K030654 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | 2003 | 1 |
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?
- Of its descendants, K040294 (Photo Medex, Inc., 2004) has gone furthest, with 306 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 | — |
What is it indicated for?
EVLT kits and Diomed DlSplus and D30plus Diode Lasers are indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023543: Evlt Kit and D15PLUS and D30PLUS Diode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023543
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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