Indications for Arthroscopic Laser Systems Use

Abstract

In the United States the Food and Drug Administration (FDA) determines the safety of specific arthroscopic laser devices and delivery systems and approves their marketing for specific procedures on specific tissues (US Department of Health and Human Services, 1988). The FDA states it does not approve the lasers but does approve the marketing of the lasers. Each manufacturer is required to go through an approval process that includes limited, controlled clinical trials. A 510(k) Approval can be obtained by competitive manufacturers if the FDA determines that the competitive manufacturer’s device is essentially similar to an already approved device. Each manufacturer has a list of procedures and tissues for which their arthroscopic laser systems are approved. The surgeon must be aware of these specific indications prior to use. Use of arthroscopic laser systems outside the United States obviously requires a different approval process relative to the specific country in question. Each surgeon must be referred to his or her specific governmental regulatory body for approval.