510(k) Report

Devices descending from K151296

9 later devices reach Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200359NuEra Tight, NuEra Tight EMSBios S.R.L.20208—
+2K240178RFG-01Zimmer Medizinsysteme GmbH20240—
+2K230659Zionic AestheticTermosalud20230—
+2K221043Doctor Tecar Plus, Doctor Tecar SmartMectronic Medicale S.R.L.20230—
+2K210867NuEra Tight RF, NuEra Tight RF PlusBios S.R.L.20214—
+3K241733Hebe (NP0000763)Novasonix Technology S.L.20250—
+3K230755NuEra Tight RF Model OptiStreamBios S.R.L.20230—
+3K223856NuEra Tight RF FamilyBios S.R.L.20230—
+3K223907NuEra Tight RF Model APMD145.M70-USBios S.R.L.20230—