# K051287: Vari-Lase Endovenous Laser Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jul 29, 2005 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
No predicates in its family tree.
131 later devices descend from it; 2 cite it directly.
0 of 132 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Vati-Lase Endovenous Laser Procedure Kit: named in the summary without a submission number
- (no number) Diomed EVLT kit: named in the summary without a submission number
- (no number) Angiodynamics EVLS kit: named in the summary without a submission number

## Most influential descendants
- 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
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own

## Indications for use
The VARI-LASE procedure kit is indicated for the treatment of varicose veins and varicosities associated with superficial reflux of the Greater Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.

Source page: https://510kreport.com/device/K051287
Methodology: https://510kreport.com/methodology