# K093502: Vari-Lase Endovenous Laser Console

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Jan 7, 2010 after 56 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). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062822: Vari-Lase Endovenous Laser Console, Model 7500, Vascular Solutions, Inc. (2006) Summary page 1.
- K051996: Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30, Diomed, Ltd. (2005) Summary page 1.

## Indications for use
The Vari-Lase procedure is indicated for the treatment of varicose veins and varicosities associated With Superficial reflux of the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extreinity.

Source page: https://510kreport.com/device/K093502
Methodology: https://510kreport.com/methodology