# K091551: Vari-Lase Platinum Bright Tip Laser Fiber

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Jun 19, 2009 after 23 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: 2 generations back to K050021 (2005). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070216: Vari-Lase Bright Tip Fiber, Vascular Solutions, Inc. (2007) Summary page 1.

## Most influential descendants
- K113140: Vari-Lase Wirefiber Laser Fiber (2011), 0 descendants of its own

## Indications for use
The Vari-Lase Platinum Bright Tip laser fiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of 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/K091551
Methodology: https://510kreport.com/methodology