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Vari-Lase Endovenous Laser Console

FDA 510(k)

Class II (US FDA 510(k))

510(k) K093502

by Vascular Solutions, Inc.

Identifiers

510(k) Number
K093502 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 Console is a semiconductor diode laser system designed for endovenous laser treatment (EVLT). It emits laser energy at 810 ± 20 nm to ablate and close incompetent superficial veins, particularly those associated with reflux in the lower extremities, such as the Great Saphenous Vein. This device is classified as a surgical laser under the GEX product code and is intended for use in clinical settings by trained medical professionals.

The console is supplied as a reusable medical device and is intended for use in controlled clinical environments. It requires proper training for operation and adherence to safety protocols, including laser safety measures. The device is regulated under FDA 510(k) clearance (K093502) and is intended for single-use per procedure, though the console itself may be reused across multiple treatments. No specific MRI safety classification is stated in the available data.

Frequently asked questions

What is the Vari-Lase Endovenous Laser Console used for?

The Vari-Lase Endovenous Laser Console is designed specifically for endovenous laser treatment (EVLT), a procedure to ablate and close incompetent superficial veins in the lower extremities. These veins often cause issues due to reflux, such as varicose veins or swelling, and the device targets veins like the Great Saphenous Vein to improve circulation and reduce symptoms. It is intended for use by trained medical professionals in controlled clinical environments.

Is the Vari-Lase Endovenous Laser Console reusable or single-use?

The Vari-Lase Endovenous Laser Console itself is a reusable medical device, meaning it can be used across multiple procedures. However, the device is intended for single-use per procedure in terms of its disposable components or consumables, such as fibers or handpieces, which may require replacement between treatments. Always follow manufacturer guidelines for proper maintenance and sterilization.

What wavelength does the Vari-Lase Endovenous Laser Console emit, and why is it significant?

The Vari-Lase Endovenous Laser Console emits laser energy at a wavelength of 810 ± 20 nm. This wavelength is significant because it allows for effective absorption by venous blood, enabling targeted ablation of the vein wall while minimizing damage to surrounding tissues. The precise wavelength helps achieve the desired therapeutic effect in EVLT procedures.

What safety measures should be followed when using the Vari-Lase Endovenous Laser Console?

The Vari-Lase Endovenous Laser Console requires adherence to strict laser safety protocols due to its high-energy output. Users must complete proper training to operate the device safely, including understanding laser safety guidelines, such as protecting patients and staff from unintended exposure, using appropriate personal protective equipment (PPE), and following facility-specific safety procedures. Always consult the manufacturer’s instructions for detailed safety guidelines.

Does the Vari-Lase Endovenous Laser Console have any specific storage requirements?

While the device itself is reusable and designed for clinical use, it should be stored in a clean, dry environment when not in use to prevent contamination or damage. Follow the manufacturer’s instructions for maintenance, calibration, and sterilization protocols to ensure optimal performance and longevity. Avoid exposure to extreme temperatures or humidity, and store it in a secure location to prevent unauthorized access.

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: Vari-Lase Endovenous Laser Console User's Manual | Manualzz, Vascular Solutions Vari-Lase - User's manual, Instructions for use, Vascular Solutions Vari-lase Endovenous Laser Console

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) K093502 24 fields · synced Oct 1, 2026