Photodynamic therapy with PHOTOFRIN is an example of combination device that comprises of two stages. In the first stage, an intravenous injection of PHOTOFRIN is given to the patient. It gets cleared from most of the tissues over 40-72 hours, but tumors, skin, and organs of the reticuloendothelial system that includes
liver and spleen retain PHOTOFRIN for a longer period. In the second phase, it is illuminated with 630 nm wavelength laser light to selectively treat tumor. So it a combination product that uses laser light with the drug called PHOTOFRIN. To get the FDA approval, this product was filed under NDA and it is class 3 device and it had clinical trials done on the patients in their last stage of the tumor. It got the PMA done along with IDE for the clinical trials.