510(k) K100388

21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS by Medical Illumination International, Inc. — Product Code FST

K100388 is an FDA 510(k) premarket notification submitted by Medical Illumination International, Inc. for the device "21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS". The FDA issued a decision of Substantially Equivalent on June 22, 2010. 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.