510(k) K053227

LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES by Medical Illumination International, Inc. — Product Code FST

K053227 is an FDA 510(k) premarket notification submitted by Medical Illumination International, Inc. for the device "LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. Medical Illumination International, Inc. has at least 4 other 510(k) clearances on record.