Medical Innovations Veinwave TC3000

The Veinwave TC3000 is a radiofrequency thermocoagulation system for small surface veins. It was developed by Medical Innovations, a company in Essex, England that its founder says has operated since 1997. It is not a laser or light device. A power generator creates a controlled pulse of 4 MHz high frequency current and delivers it through a fine needle, heating and coagulating the target vessel. FDA cleared it on June 12, 2009 under K083352, with Newlands Clinical Trials of Bolton, England as the submitter. It is a prescription device, classified as an electrosurgical cutting and coagulation device.

The cleared indications are epilation and thermocoagulation of spider veins or telangiectasia on the lower limbs. The 510(k) summary lists two main controls. Pulse length runs from 0.2 to 1 second in 0.1 second steps, and power runs from 30 to 60 percent in 5 percent steps. The needles are sterile, single-use and disposable. Newlands bought them from Ballet Technologies, which lists them as accessories for needle-type high frequency epilators.

Veinwave, TC3000 and Veinwave/TC3000 are names for the same unit, and the FDA file uses the combined form. Because it works by needle rather than light, it has no wavelength, filter or cooling tip, and that separates it from vascular lasers and IPL systems used on the same veins. A July 2009 trade report said the company would partner with Sovereign Medical Health of London to build US distribution after the clearance, and described the device's use in the UK for spider veins and rosacea.

A buyer will want to see the generator power up and show both settings, plus the needle holder, its cable and any footswitch or accessories that came with it. Needles are a single-use consumable, so confirm that compatible needles are still available and note how many sealed, in-date needles come with the system. Photos of the rating label, the front panel and the accessory kit help a dealer make a firm offer.