About This 510(k) Submission
K053227 is an FDA 510(k) clearance for the LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES, a Light, Surgical, Fiberoptic (Class II — Special Controls, product code FST), submitted by Medical Illumination International, Inc. (San Fernando, US). The FDA issued a Cleared decision on January 13, 2006, 57 days after receiving the submission on November 17, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.