510(k) K092337

PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS by Baylis Medical Co., Inc. — Product Code GXI

K092337 is an FDA 510(k) premarket notification submitted by Baylis Medical Co., Inc. for the device "PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS". The FDA issued a decision of Substantially Equivalent on October 16, 2009. The device falls under product code GXI (Probe, Radiofrequency Lesion), a Class II device regulated under 21 CFR 882.4725. Baylis Medical Co., Inc. has at least 10 other 510(k) clearances on record.