510(k) K003489

NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 by Medical Illumination International, Inc. — Product Code FSS

K003489 is an FDA 510(k) premarket notification submitted by Medical Illumination International, Inc. for the device "NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8". The FDA issued a decision of Substantially Equivalent on February 2, 2001. The device falls under product code FSS (Light, Surgical, Floor Standing), a Class II device regulated under 21 CFR 878.4580. Medical Illumination International, Inc. has at least 4 other 510(k) clearances on record.