# K032805: Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Oct 1, 2003 after 22 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
Longest line of descent: 10 generations back to K943450 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030654: Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit, Vascular Solutions, Inc. (2003) Summary page 1.

## 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/K032805
Methodology: https://510kreport.com/methodology