# K070216: Vari-Lase Bright Tip Fiber

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Mar 16, 2007 after 52 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 K050021 (2005). 1 ancestor in all.
16 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050021: Vascular Solutions Vari-Lase Endovenous Laser Procedure Kit, Vascular Solutions, Inc. (2005) Summary page 1.
- (no number) Vari-Lase Fiber: named in the summary without a submission number

## Most influential descendants
- K072332: Vari-Lase Wire Fiber (2008), 14 descendants of its own
- K121861: Smith & Nephew Ultra Fast-Fix Meniscal Repair System, Smith & Nephew Ultra Fast-Fix AB Meniscal Repair System, Smith & N (2012), 12 descendants of its own
- K190125: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2019), 2 descendants of its own
- K221731: FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire (2022), 1 descendant of its own
- K203393: Fast-Fix Flex (2021), 1 descendant of its own

## Indications for use
The Vari-Lase® Bright Tip fiber 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/K070216
Methodology: https://510kreport.com/methodology