# K032204: Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Aug 20, 2003 after 33 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K000737: Coaxial Dilator Set, Xentek Medical, Inc. (2000). Our reading of the summary gave K000737, FDA’s number for Coaxial Dilator Set (Xentek Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “VARI-LASE Procedure Kit”. Kept off the family tree. 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/K032204
Methodology: https://510kreport.com/methodology