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Vari-Lase Endovenous Laser Procedure Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K050021

by Vascular Solutions, Inc.

Identifiers

510(k) Number
K050021 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Vari-Lase Endovenous Laser Procedure Kit is a medical device classified as an endovenous laser ablation system (product code GEX). It is designed for the thermal closure of superficial veins, specifically targeting varicose veins and varicosities caused by reflux in the greater saphenous vein system. The kit employs laser energy to induce controlled thermal damage, promoting vein occlusion and subsequent fibrosis as part of endovenous treatment protocols.

This kit is supplied as a single-use, non-sterile assembly and requires sterile preparation prior to use. It is intended for use in clinical settings by trained healthcare professionals, including vascular surgeons and interventional radiologists. The device is regulated under FDA 510(k) clearance (K050021) and is not MRI-compatible. Storage conditions must adhere to manufacturer guidelines to maintain device integrity, though specific sterility or shelf-life details are not provided in the submitted data.

Frequently asked questions

What is the primary purpose of the Vari-Lase Endovenous Laser Procedure Kit?

The kit is designed for thermal closure of superficial veins, specifically targeting varicose veins and varicosities caused by reflux in the greater saphenous vein system, using laser energy to induce controlled thermal damage.

Is the Vari-Lase kit single-use or reusable?

The kit is supplied as a single-use, non-sterile assembly that requires sterile preparation prior to use, meaning it is intended for one patient procedure only.

What healthcare professionals are qualified to use this device?

The device is intended for use in clinical settings by trained healthcare professionals, including vascular surgeons and interventional radiologists who have expertise in endovenous treatment protocols.

What regulatory status does the Vari-Lase kit have?

The device is regulated under FDA 510(k) clearance (K050021) and has been determined to be substantially equivalent to other legally marketed devices.

Is the Vari-Lase kit compatible with MRI procedures?

No, the device is not MRI-compatible, meaning it should not be used in patients undergoing MRI scans due to potential safety concerns.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vascular Solutions Vari-lase Endovenous Laser Procedure Kit, Vascular Solutions Vari-Lase Bright Tip Endovenous Laser Procedure Kit ..., Vascular Solutions Vari-Lase Bright Tip Endovenous Laser Procedure Kit ..., Vascular Solutions Vari-lase Endovenous Laser Procedure Kit, VARI-LASE® BRIGHT TIP™ Endovenous Laser Procedure Kit and

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Vascular Solutions, Inc.

Sources (1)

  • FDA 510(k) K050021 24 fields · synced Sep 19, 2026