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Modification to Vascular Solutions Vari-lase Endovenous Laser Procedure Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K032204

by Vascular Solutions, Inc.

Identifiers

510(k) Number
K032204 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)

This device is a powered laser surgical instrument classified under product code GEX. It is a modification to the Vascular Solutions Vari-lase Endovenous Laser Procedure Kit.

The device received FDA 510(k) clearance (K032204) on August 20, 2003, and is classified as a Class II device with special controls. It is manufactured by Vascular Solutions, Inc. in Minneapolis, Minnesota.

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: Modification to Vascular Solutions Vari-lase Endovenous Laser Procedure Kit, K032204 FDA 510(k) - MODIFICATION TO VASCULAR SOLUTIONS VARI..., PDF K032805 Modification to Vascular Solutions Vari-lase Endovenous Laser ...

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) K032204 24 fields · synced Oct 1, 2026