510(k) K242057

COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) by Avanos Medical, Inc. — Product Code GXD

K242057 is an FDA 510(k) premarket notification submitted by Avanos Medical, Inc. for the device "COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)". The FDA issued a decision of Substantially Equivalent on August 14, 2024. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Avanos Medical, Inc. has at least 7 other 510(k) clearances on record.