510(k) K100395

HARMONY VLED SURGICAL LIGHTNING SYSTEM by STERIS Corporation — Product Code FST

K100395 is an FDA 510(k) premarket notification submitted by STERIS Corporation for the device "HARMONY VLED SURGICAL LIGHTNING SYSTEM". The FDA issued a decision of Substantially Equivalent on March 17, 2010. The device falls under product code FST (Light, Surgical, Fiberoptic), a Class II device regulated under 21 CFR 878.4580. STERIS Corporation has at least 10 other 510(k) clearances on record.