# K062822: Vari-Lase Endovenous Laser Console, Model 7500

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 21, 2006 after 62 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: 9 generations back to K943450 (1995). 29 ancestors in all.
132 later devices descend from it; 3 cite it directly.
0 of 162 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033237: Vascular Solutions Vari-Lase Endovenous Laser Console, Vascular Solutions, Inc. (2003) Summary page 1.
- K023543: Evlt Kit and D15PLUS and D30PLUS Diode, Diomed, Inc. (2002) Summary page 1.
- K041957: Evlt Kit and the D15PLUS and D30PLUS Diode Lasers, Diomed, Inc. (2004) Summary page 1.

## Most influential descendants
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The Vari-LaseTM 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 extremity.

Source page: https://510kreport.com/device/K062822
Methodology: https://510kreport.com/methodology