# K090084: Elation Endovenous Laser Procedure Kit Universal Fluid Dispensing Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Mar 6, 2009 after 53 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 K051287 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070378: Angiodynamics, Inc. 600UM Fiber and Venacure Procedure Kit, AngioDynamics, Inc. (2007) Summary page 1.
- K051287: Vari-Lase Endovenous Laser Procedure Kit, Vascular Solutions, Inc. (2005) Summary page 1.

## Indications for use
The ELAtion™ Endovenous Laser 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. The kit is intended to be used with an 810 nm, 940 nm, or 980 nm laser.

Source page: https://510kreport.com/device/K090084
Methodology: https://510kreport.com/methodology