# K050021: Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Mar 18, 2005 after 72 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
17 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vari-Lase Endovenous Laser Procedure Kit: named in the summary without a submission number

## Most influential descendants
- K070216: Vari-Lase Bright Tip Fiber (2007), 16 descendants of its own
- K072332: Vari-Lase Wire Fiber (2008), 14 descendants of its own
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N (2012), 12 descendants of its own
- K190125: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2019), 2 descendants of its own
- K221731: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2022), 1 descendant of its own

## Indications for use
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Source page: https://510kreport.com/device/K050021
Methodology: https://510kreport.com/methodology