# K030654: Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jun 18, 2003 after 107 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943450 (1995). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023543: Evlt Kit and D15PLUS and D30PLUS Diode, Diomed, Inc. (2002) Summary page 1.
- K023624: SLT Venous Fiber Delivery Systems, Model: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921, Surgical Laser Technologies, Inc. (2003) Summary page 1.
- (no number) Angiodynamics ELVS Kit: named in the summary without a submission number

## Most influential descendants
- K032805: Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit (2003), 0 descendants of its own

## Recalls of this device
- Oct 9, 2003 · Not classified · Z-0101-04: An internal gasket of the Fiber Lock component of the Vari-Lase Kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary

## 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/K030654
Methodology: https://510kreport.com/methodology