# K080104: Vari-Lase Endovenous Laser Console, Model 7542

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Mar 26, 2008 after 72 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)
- K993815: Uni-Laser 430, Medart Corp. (2000) Summary page 1.
- K062822: Vari-Lase Endovenous Laser Console, Model 7500, Vascular Solutions, Inc. (2006) Summary page 1.
- K033237: Vascular Solutions Vari-Lase Endovenous Laser Console, Vascular Solutions, Inc. (2003) Summary page 2.

## Indications for use
The Vari-Lase® 90W laser console is indicated for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels) and in contact mode, for the vaporization, ablation, incision, and excision of soft tissue. The Vari-Lase® procedure is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Source page: https://510kreport.com/device/K080104
Methodology: https://510kreport.com/methodology