About This 510(k) Submission
K100388 is an FDA 510(k) clearance for the 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS, 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 June 22, 2010, 126 days after receiving the submission on February 16, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.