510(k) K181864

Polaris RF Ablation System by Baylis Medical Company, Inc. — Product Code GXD

K181864 is an FDA 510(k) premarket notification submitted by Baylis Medical Company, Inc. for the device "Polaris RF Ablation System". The FDA issued a decision of Substantially Equivalent on January 2, 2019. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Baylis Medical Company, Inc. has at least 10 other 510(k) clearances on record.