Chromogenex receives FDA 510(K) approval for its Chromolite EP skin-treatment system

August 1, 2008 -- Chromogenex PLC (Llanelli, South Wales, U.K.) says it has received Section 510(K) approval from the Food and Drug Administration (FDA) to market and sell its Chromolite EP (Enhanced Pulse), in the United States. Chromolite EP is the company's newest intense pulsed light system for the treatment of unwanted hair, photo rejuvenation and active acne. It is specially designed as a self-contained, portable device for use within a clinic or medspa environment.

Chromogenex chairman Peter McGuinness said, "We are delighted to have received FDA approval for our latest version of the Chromolite product. With the US currently accounting for approximately 50 per cent of the world healthcare market and the Chromolite representing approximately 40 per cent. of the company's sales, this is a significant achievement in helping drive further revenues."

Chromolite EP uses proprietary Smartlite Dual Phase Technology (DPT), which produces high levels of light energy -- and promises fast results. The technology uses a combination of enclosed waveguide and a special reflecting cavity at the rear of the flash lamp source to increase transmission of light energy into tissue significantly compared with standard intense pulsed light (IPL). Smartlite delivers a combination of yellow and red light combined with DPT to increase the efficiency and results.