510(k) K081729

MODIFICATION TO GFX NERVE ABLATION SYSTEM by Bioform Medical, Inc. — Product Code GXD

K081729 is an FDA 510(k) premarket notification submitted by Bioform Medical, Inc. for the device "MODIFICATION TO GFX NERVE ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on August 7, 2008. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Bioform Medical, Inc. has at least 2 other 510(k) clearances on record.