About This 510(k) Submission
K003489 is an FDA 510(k) clearance for the NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8, a Light, Surgical, Floor Standing (Class II — Special Controls, product code FSS), submitted by Medical Illumination International, Inc. (San Fernando, US). The FDA issued a Cleared decision on February 2, 2001, 81 days after receiving the submission on November 13, 2000. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.