# K033237: Vascular Solutions Vari-Lase Endovenous Laser Console

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Nov 20, 2003 after 45 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: 1 generation back to K991659 (1999). 2 ancestors in all.
133 later devices descend from it; 2 cite it directly.
0 of 136 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.
- K991659: Uni-Laser 425P Diode Laser System & Accessories, Medart Corp. (1999)

## Most influential descendants
- K062822: Vari-Lase Endovenous Laser Console, Model 7500 (2006), 132 descendants of its own
- 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

## Indications for use
VARI-LASE is indcated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein.

Source page: https://510kreport.com/device/K033237
Methodology: https://510kreport.com/methodology