510(k) · Cleared
Recalled · 2011Vari-Lase Wire Fiber
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 Jan 10, 2008 as substantially equivalent to K070216 (Vascular Solutions, Inc., 2007) after a 143-day review. Its family tree reaches back 2 generations to 2005. 14 later devices descend from it. It has been recalled once.
- Decided
- Jan 10, 2008
- Review
- 143 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K050021 (2005). 14 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK050021 Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc. · 2005
- 1 generation backK070216 Vari-Lase Bright Tip FiberVascular Solutions, Inc. · 2007
- This deviceK072332 Vari-Lase Wire FiberVascular Solutions, Inc. · 2008
- Descendant · cites it directly · 12 of its ownK121861 Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew…Smith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 2 of its ownK190125 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2019
- Descendant · 3 generations on · 1 of its ownK221731 FiberStitch Implant, Curved with two Polyester Implants and 2-0…T.A.G. Medical Products Corporation, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK203393 Fast-Fix FlexSmith & Nephew, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK153667 TRUESPAN Meniscal Repair SystemMedos International SARL · 2016
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K121861Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB…Smith & Nephew, Inc. · 2012 · cites it directly12descendants
- K190125FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2019 · 2 generations on2descendants
- K221731FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch…T.A.G. Medical Products Corporation, Ltd. · 2022 · 3 generations on1descendant
- K203393Fast-Fix FlexSmith & Nephew, Inc. · 2021 · 2 generations on1descendant
- K153667TRUESPAN Meniscal Repair SystemMedos International SARL · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K050021 | Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit | Vascular Solutions, Inc. | 2005 | — |
| −1 | K070216 | Vari-Lase Bright Tip Fiber | Vascular Solutions, Inc. | 2007 | — |
| 0 (this device) | K072332 | Vari-Lase Wire Fiber | Vascular Solutions, Inc. | 2008 | — |
| +1 | K121861 | Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra… | Smith & Nephew, Inc. | 2012 | — |
| +2 | K190125 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2019 | — |
| +3 | K221731 | FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire… | T.A.G. Medical Products Corporation, Ltd. | 2022 | — |
| +2 | K203393 | Fast-Fix Flex | Smith & Nephew, Inc. | 2021 | — |
| +2 | K153667 | TRUESPAN Meniscal Repair System | Medos International SARL | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K070216 | Vari-Lase Bright Tip FiberSummary page 1…Surgery and in Dermatology (21 CFR 870.4810, Product Code GEX) Predicate Device Vari-Lase Endovenous BrightTm Tip Fiber (K070216) manufactured by Vascular Solutions, Inc. Device Description The Vari-Lase Wire Fiber is a 600zrn core laser fiber that is 3… | 2007 |
What descends from it? (14)
See all 142 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 |
|---|---|---|---|---|
| Jan 10, 2011 | Not classified | Z-1521-2011 | Nonconforming Material/Component | Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896. Recently it was reported that the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K121861 (Smith & Nephew, Inc., 2012) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K070216.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 VARI-LASE Wire Fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and 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/K072332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072332: Vari-Lase Wire Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072332
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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