510(k) · Cleared
ClearedDiomed 15 Diode Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diomed, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jan 22, 2002 as substantially equivalent to K974521 (Vnus Medical Technologies, Inc., 1998) and 2 other predicates after a 179-day review. Its family tree reaches back 7 generations to 1995. 714 later devices descend from it.
- Decided
- Jan 22, 2002
- Review
- 179 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K943450 (1995). 22 ancestors in all, the oldest K800617 (1980). 714 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 1 generation backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- This deviceK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- Descendant · cites it directly · 695 of its ownK020339 Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas…Dornier Medtech America, Inc. · 2002
- Descendant · 2 generations on · 680 of its ownK030186 Polris LVSyneron Medical, Ltd. · 2003
- Descendant · 3 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · 4 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · 3 generations on · 456 of its ownK052324 Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005
Showing 5 of 714 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 714 · See all- K020339Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser…Dornier Medtech America, Inc. · 2002 · cites it directly695descendants
- K030186Polris LVSyneron Medical, Ltd. · 2003 · 2 generations on680descendants
- K031671Polaris WRSyneron Medical, Ltd. · 2003 · 3 generations on678descendants
- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 4 generations on476descendants
- K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd. · 2005 · 3 generations on456descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −6 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −1 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| 0 (this device) | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| +1 | K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D… | Dornier Medtech America, Inc. | 2002 | — |
| +2 | K030186 | Polris LV | Syneron Medical, Ltd. | 2003 | — |
| +3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +3 | K052324 | Polaris LV, Lva Applicator | Syneron Medical, Ltd. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 10 | 0 |
| 2008 | 21 | 0 |
| 2009 | 17 | 0 |
| 2010 | 20 | 0 |
| 2011 | 16 | 0 |
| 2012 | 17 | 0 |
| 2013 | 21 | 0 |
| 2014 | 30 | 0 |
| 2015 | 25 | 0 |
| 2016 | 40 | 0 |
| 2017 | 35 | 0 |
| 2018 | 36 | 0 |
| 2019 | 25 | 0 |
| 2020 | 40 | 0 |
| 2021 | 32 | 0 |
| 2022 | 51 | 0 |
| 2023 | 45 | 0 |
| 2024 | 76 | 0 |
| 2025 | 89 | 0 |
| 2026 | 52 | 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 |
|---|---|---|---|
| * | K974521 | Vnus Closure SystemSummary page 1…GaAlAs Semiconductor Diode Laser Device, Electrosurgical, Cutting & Coagulation & Accessories (see: 21 CFR 878.4400). Product Code: GEI. Panel: 79 VNUS Closure System (K974521, K003092, K982816) Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is a semiconductor diode lasers operating at 810 + 20 mi… | 1998 |
| * | K003092 | Modification to Vnus Closure SystemSummary page 1…miconductor Diode Laser Device, Electrosurgical, Cutting & Coagulation & Accessories (see: 21 CFR 878.4400). Product Code: GEI. Panel: 79 VNUS Closure System (K974521, K003092, K982816) Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is a semiconductor diode lasers operating at 810 + 20 microns and… | 2000 |
| * | K982816 | Vnus Closure SystemSummary page 1…or Diode Laser Device, Electrosurgical, Cutting & Coagulation & Accessories (see: 21 CFR 878.4400). Product Code: GEI. Panel: 79 VNUS Closure System (K974521, K003092, K982816) Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is a semiconductor diode lasers operating at 810 + 20 microns and associat… | 1999 |
What descends from it? (714)
See all 7146 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020339 | Dornier Diode Laser Family Medilas D, Medilas D Skinpulse & Medilas D Skinpulse S Laser… | 2002 | 695 |
| K041957 | Evlt Kit and the D15PLUS and D30PLUS Diode Lasers | 2004 | 297 |
| K040921 | Cooltouch, Model NS 160 | 2004 | 204 |
| K051996 | Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30 | 2005 | 89 |
| K023624 | SLT Venous Fiber Delivery Systems, Model… | 2003 | 2 |
| K070353 | Kelsey Intersitital Laser Therapy System | 2007 | 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 8 months on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K020339 (Dornier Medtech America, Inc., 2002) has gone furthest, with 695 descendants of its own.
- 5 other devices also cite its predicate K974521.
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?
Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with
superficial vein reflux.
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/K012398 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012398: Diomed 15 Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012398
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026