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The VeinGogh device is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.

The VeinGogh instrument is intended for the treatment of lower limb spider vein or telangiectasia by thermocoagulation. Users could wear a magnification aid to ensure adequate vision of the treatment area. The user could wear a face shield and gloves as indicated by office practices. The user inserts the needle point in a telangiectasia at a right angle to the vein after setting the instrument's control panel setting of time and pulse or using the instrument's Auto-Pulse functionality. Pulses are intended to be created every 2-3 mm along a vein. The user should clean the needle point frequently between vein insertions with a sterile compress. The instrument's regulated, small, high frequency current is delivered to the vessel, in a process called "Ohmic Thermolysis," during which the electrical resistivity selectively thermocoagulates small blood vessels using microbursts of high-frequency electrical energy delivered into the vessel. This Microburst Technology™ of fixed amplitude energy within the vessel is converted to heat instantly, coagulating the blood and collapsing the vessel wall. The pulse train encompasses sharp, precise peaks to minimize the risk of damage and deliver consistent results. The high frequency current is delivered into each vessel through the sterile needle as positioned and inserted by the medical professional. Trained medical professionals can deliver fast, immediate results, which are consistent and repeatable, with little or no discomfort to the patient. Experienced medical professionals can treat vessels up to 0.3 mm throughout the body. Typically, only a single treatment is required. Multiple spider veins or telangiectasias are treated subepidermally along each veins length, typically every 2-3 mm. The instrument has a foot switch that is used to cause the instrument to send one pulse with each pressing of the switch. The instrument also has a Ballet Needle holder and uses single use Ballet K3 and K2 stainless steel and gold needles, which are not intended for reuse. The instrument is designed to accommodate needle holders and needles which are equivalent to Ballet Needle Holders and Needles, specifically, those products having the same or similar labeling and listed by their manufacturer under the same regulation and product code. The instrument has firmware that interacts with the Control Panel push buttons to provide the professional user with operational controls. The firmware cannot be edited or changed by the user. No bandage or other treatment of the thermocoagulated area is required. Typical treatment times are under 20 minutes and the treatment area (40-50 cm) may receive 300 to 600 impulses during a treatment. The instrument is not designed to treat feeder vessels or larger vessels deep beneath the skin's surface. The instrument's dimensions, 16.1 in wide x 13 inches deep x 5.9 inches high and weight, 5.7 pound, allow the device to be used in small or large medical offices on any convenient flat surface. The instrument is intended to be moved in a safe and effective manner, such as movement from one room to another in a medical office or clinic environment. The instrument is powered by a grounded 120 Volt power source from a wall or floor electrical receptacle. The electrical components are intended to be safe and effective and easily accessed by a qualified technician for any appropriate replacement or repair. The VeinGogh instrument has a 4MHz frequency wave output, and a maximum voltage output of 205Vpp +/-10%. Microburst Technology is a Trade Mark of Refine USA, LLC, Jacksonville Beach, FL