FDA approves Laserscope treatments

17 Jun 2002

The Food and Drug Administration gave Laserscope clearance to market its erbium-laser system for laser skin resurfacing. The system had previouslybeen approved by the FDA for surgical incision and excision, vaporization, and coagulation of all soft tissue. With the FDA approval, Laserscope plans tointroduce a smaller, portable, next-generation laser early next year. The FDA also gave Laserscope an "approvable letter" on its supplemental premarketapproval application for the photodynamic-therapy treatment of certain types of lung cancer using the laser systems and the drug Photofrin. A final FDAdecision on the premarket approval application will come if the FDA's Center for Drug Evaluation approves the application for Photofrin and its bundledlaser delivery systems. (courtesy Laser Focus World)