• Basis for classification of surgical laser devices
• Laser standards
FDA regulates radiation emitting electronic products. The purpose is to prevent unnecessary exposure to radiation due to the use of these products. There are specific requirements that apply to all radiation-emitting electronic products in order to comply with the provisions of the Food, Drug and Cosmetic Act. If the product is also a medical device,71 the product must also comply with the medical device regulations. Medical lasers have been categorized either in Class II or Class III, depending upon the specific application involved.