510(k) Report

Devices descending from K133739

39 later devices reach Trusculpt through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173676A-FITHironic Co., Ltd.20181—
+1K162828Winback Back 3SEWinback USA Corp201713—
+1K162512truSculptCutera, Inc.20165—
+1K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device…Indiba USA, Inc.201611—
+1K151296Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L.201591
+2K242207Noable LaserDaeju Meditech Engineering Co., Ltd.20250—
+2K242175XOD Diathermia Radiofrequency DeviceXod, Inc.20250—
+2K241107Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba…Indiba S. A. U.20250—
+2K232966Fisiowarm 7.0Golden Star Srl20240—
+2K243164INDIBA COMPACT devicesIndiba S. A. U.20240—
+2K213256ThermoTKZimmer Medizinsysteme GmbH20230—
+2K230412Symmed Elite AestheticTermosalud20231—
+2K220014RshockSwims America Corp20230—
+2K214090Back 3 COLORSwims America Corp20222—
+2K211207Diacare 7000Globus Sport and Health Technologies, LLC20220—
+2K200359NuEra Tight, NuEra Tight EMSBios S.R.L.20208—
+2K191202Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L.20204—
+2K183693Doctor TecarMectronic Medicale S.R.L.20190—
+2K181893T-PLUSWintecare SA20190—
+2K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+2K172004truSculptCutera, Inc.20173—
+3K243716Zionic Pro Max (Radiofrequency)Termosalud S.L.20250—
+3K240178RFG-01Zimmer Medizinsysteme GmbH20240—
+3K230167BACK 4Swims America Corp20230—
+3K230037BACK 3Swims America Corp20230—
+3K230659Zionic AestheticTermosalud20230—
+3K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+3K221043Doctor Tecar Plus, Doctor Tecar SmartMectronic Medicale S.R.L.20230—
+3K221407truSculpt iDCutera, Inc.20222—
+3K210867NuEra Tight RF, NuEra Tight RF PlusBios S.R.L.20214—
+4K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+4K241733Hebe (NP0000763)Novasonix Technology S.L.20250—
+4K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+4K230755NuEra Tight RF Model OptiStreamBios S.R.L.20230—
+4K223856NuEra Tight RF FamilyBios S.R.L.20230—
+4K223907NuEra Tight RF Model APMD145.M70-USBios S.R.L.20230—
+4K223110truSculpt iDCutera, Inc.20221—
+5K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+5K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—