510(k) · Cleared
ClearedModification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vascular Solutions, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 1, 2003 as substantially equivalent to K030654 (Vascular Solutions, Inc., 2003) after a 22-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Oct 1, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K943450 (1995). 28 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 2 generations backK023624 SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc. · 2003
- 1 generation backK030654 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · Recalled
- This deviceK032805 Modification to Vascular Solutions Vari-Lase Endovenous Laser…Vascular Solutions, Inc. · 2003
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 5 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 4 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 3 generations backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- 2 generations backK023624 SLT Venous Fiber Delivery Systems, Model…Surgical Laser Technologies, Inc. · 2003
- 1 generation backK030654 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2003 · Recalled
- This deviceK032805 Modification to Vascular Solutions Vari-Lase Endovenous Laser…Vascular Solutions, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −5 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −4 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −3 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| −2 | K023624 | SLT Venous Fiber Delivery Systems, Model… | Surgical Laser Technologies, Inc. | 2003 | — |
| −1 | K030654 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2003 | 1 |
| 0 (this device) | K032805 | Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2003 | — |
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 |
| 2002 | 3 | 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 |
|---|---|---|---|
| * | K030654 | Vascular Solutions Vari-Lase Endovenous Laser Procedure KitSummary page 1…o document the safety and effectiveness of h s modhed procedure kit. Predicate Devices: \’ARI-LASE Procedure Kit (I(030654) Conclusions: The VARI-L4SE Procedure Kit is substantially equivalent… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 8 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 2 of the 28 ancestors have a recall of any class.
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 VARI-LASE procedure kit is 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/K032805 · printed Nov 3, 2026
Cite this page
510(k) Report. “K032805: Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K032805
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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