Lightguide Receives FDA 510(k) Clearance for Surgical Laser Fibers.

Lightguide is proud to announce that our Surgical Laser Fibers have received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance affirms that our products meet the necessary requirements to be marketed in the United States, allowing us to further support medical device companies as they enter or expand their presence in one of the world’s most demanding healthcare markets.

Building on our track record of delivering high-quality medical solutions, Lightguide also holds a variety of internationally recognized certifications, including ISO 13485, ISO 9001, and compliance with the EU Medical Device Directive 93/42. This robust foundation enables us to provide comprehensive regulatory and quality management support to our customers, ensuring they can confidently navigate U.S. market requirements.

With FDA clearance now in place, Lightguide is poised to offer its Surgical Laser Fibers and expert guidance, helping our partners achieve seamless market entry and successful product adoption across the United States.