510(k) K093185

OWL UNIVERSAL RF SYSTEM URF-3AP (ML) by Diros Technology, Inc. — Product Code GXD

K093185 is an FDA 510(k) premarket notification submitted by Diros Technology, Inc. for the device "OWL UNIVERSAL RF SYSTEM URF-3AP (ML)". The FDA issued a decision of Substantially Equivalent on January 22, 2010. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Diros Technology, Inc. has at least 7 other 510(k) clearances on record.