510(k) Report

Devices descending from K122389

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133739TrusculptCutera, Inc.201439—
+1K132949PellefirmEllman International, Inc.201448—
+2K173676A-FITHironic Co., Ltd.20181—
+2K171262TempSureCynosure, Inc.201716—
+2K162828Winback Back 3SEWinback USA Corp201713—
+2K162512truSculptCutera, Inc.20165—
+2K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device…Indiba USA, Inc.201611—
+2K151296Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)Bios S.R.L.201591
+2K143040Exilis XPBTL Industries, Inc.201516—
+3K242207Noable LaserDaeju Meditech Engineering Co., Ltd.20250—
+3K242175XOD Diathermia Radiofrequency DeviceXod, Inc.20250—
+3K241107Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba…Indiba S. A. U.20250—
+3K232966Fisiowarm 7.0Golden Star Srl20240—
+3K243164INDIBA COMPACT devicesIndiba S. A. U.20240—
+3K213256ThermoTKZimmer Medizinsysteme GmbH20230—
+3K230412Symmed Elite AestheticTermosalud20231—
+3K220014RshockSwims America Corp20230—
+3K214090Back 3 COLORSwims America Corp20222—
+3K211207Diacare 7000Globus Sport and Health Technologies, LLC20220—
+3K200359NuEra Tight, NuEra Tight EMSBios S.R.L.20208—
+3K191202Capenergy - C100, C200, C300, C400, C50Capenergy Medical S.L.20204—
+3K183371Deka Tiac 1El..En. Electroic Engineering Spa20192—
+3K190678TempSureCynosure, Inc.201914—
+3K183693Doctor TecarMectronic Medicale S.R.L.20190—
+3K181893T-PLUSWintecare SA20190—
+3K182365TempSure SystemCynosure, Inc.201815—
+3K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+3K172004truSculptCutera, Inc.20173—
+3K163176Exilis XP IIBTL Industries, Inc.20170—
+3K161551TR-100BTL Industries, Inc.20161—
+3K150720XP3000BTL Industries, Inc.20159—
+4K243716Zionic Pro Max (Radiofrequency)Termosalud S.L.20250—
+4K240178RFG-01Zimmer Medizinsysteme GmbH20240—
+4K230167BACK 4Swims America Corp20230—
+4K230037BACK 3Swims America Corp20230—
+4K230659Zionic AestheticTermosalud20230—
+4K222260Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500Capenergy Medical S.L.20233—
+4K221043Doctor Tecar Plus, Doctor Tecar SmartMectronic Medicale S.R.L.20230—
+4K221407truSculpt iDCutera, Inc.20222—
+4K211091Deka Tiac IIEl.En Electronic Engineering Spa20211—
+4K210867NuEra Tight RF, NuEra Tight RF PlusBios S.R.L.20214—
+4K193201BTL-785FBtl20208—
+4K200241TempSure SystemCynosure, LLC202013—
+4K190023BTL-084BTL Industries, Inc.20190—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K260647SpecchioEl.En S.P.A.20260—
+5K241733Hebe (NP0000763)Novasonix Technology S.L.20250—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K242553MIRARI® Cold Plasma System ( GV-M2-01)General Vibronics, Inc.20240—
+5K230755NuEra Tight RF Model OptiStreamBios S.R.L.20230—
+5K223856NuEra Tight RF FamilyBios S.R.L.20230—
+5K223907NuEra Tight RF Model APMD145.M70-USBios S.R.L.20230—
+5K223110truSculpt iDCutera, Inc.20221—
+5K212891TempSure SystemCynosure, LLC20221—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K210129RF Thermal SystemLuvo Medical Technologies, Inc.20211—
+6K252888NeoSculpt PlusS&M Medical Co., Ltd.20260—
+6K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K223292TempSure SystemCynosure, LLC20220—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K233849BTL-499BTL Industries, Inc.20240—
+7K233604BTL-785SBTL Industries, Inc.20243—
+8K253750BTL-785NEHBTL Industries, Inc.20260—
+8K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—