510(k) Report

Devices descending from K861248

63 later devices reach Curapuls 419 Diathermy Unit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K022458Auto*Therm 395, Model ME 395Mettler Electronics Corp.200262—
+2K120093BTL EliteBTL Industries, Inc.20122—
+2K083433Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601Chattanooga Group2009611
+3K182363BTL-703BTL Industries, Inc.20191—
+3K161862ThermoProZimmer Medizinsysteme GmbH20161—
+3K121123Biofusionary BebeRocky Mountain Biosystems, Inc.20140—
+3K090221Reaction SystemViora, Ltd.200954—
+4K252963BTL-899TTBTL Industries, Inc.20260—
+4K243112Curapuls 670Enraf-Nonius, B.V.20250—
+4K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K143554Venus Legacy CXVenus Concept, Ltd.201517—
+4K150035V10 systemViora, Ltd.201531—
+4K141904Viora V-TouchViora, Ltd.20140—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+5K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+5K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+5K212561MTX-C1Ilooda Co,., Ltd.20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K202780SectumNeauvia North America20211—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+5K190743Venus BlissVenus Concept USA, Inc.20194—
+5K183450EmBody SystemInmode MD, Ltd.20198—
+5K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+5K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+5K170637sensiFirmEl Global Trade, Ltd.20173—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K161043Profound SystemSyneron Candela Corporation20160—
+5K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+5K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+5K153568InMode Plus SystemInmode MD, Ltd.201618—
+5K152611V20 systemViora, Ltd.20164—
+5K142093V20 SystemViora, Ltd.201432—
+6K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+6K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+6K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+6K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+6K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+6K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+6K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+6K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+6K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+6K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+6K191855EmFace DeviceInmode MD, Ltd.20191—
+6K181095RF-ReliefEl Global Trade, Ltd.20181—
+6K172302InMode PLUS SystemInmode MD, Ltd.201713—
+7K253542Apollo Quattro (APQ-10M)Weero Co., Ltd.20260—
+7K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+7K250734OptiLUV DevicePollogen, Ltd.20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K241433EVE Synergy (EVE-20M)Weero Co., Ltd.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+7K240992eMVFit (MVF-10M)Weero Co., Ltd.20240—
+7K230167BACK 4Swims America Corp20230—
+7K230037BACK 3Swims America Corp20230—