Luxtec Gets FDA Approval to Market Arthroscopes
WORCESTER, Mass., Dec. 30 -- Luxtec Corp. announced that the US Food and Drug Administration has approved the US marketing of a line of arthroscopes produced by Luxtec's subsidiary, Fiber Imaging Technologies (FIT), and FIT's German joint-venture partner, Schoelly Fiberoptic GmbH.
The FDA's Section 510(k) approval allows FIT to offer the arthroscopic telescopes to OEMs for inclusion in vision subsystems sold to surgeons and physicians. The rigid-rod arthroscopes are used in conjunction with lighting, video and monitoring products to improve visibility around operative sites and to enable surgeons to document arthroscopic procedures performed on the knee, ankle, shoulder, elbow, wrist and jaw. Luxtec said that its own line of light sources, vision systems, fiber optic cables and cameras could be used with the arthroscopes.
MORE FROM PHOTONICS MEDIA