# K113140: Vari-Lase Wirefiber Laser Fiber

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Dec 22, 2011 after 58 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: 3 generations back to K050021 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072332: Vari-Lase Wire Fiber, Vascular Solutions, Inc. (2008) Summary page 1.
- K091551: Vari-Lase Platinum Bright Tip Laser Fiber, Vascular Solutions, Inc. (2009) Summary page 1.

## Indications for use
The Vari-Lase WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for the treatment of incompetence and reflux of superficial veins in the lower extremity.

Source page: https://510kreport.com/device/K113140
Methodology: https://510kreport.com/methodology