510(k) Report

Devices descending from K083433

61 later devices reach Intelect SWD 100, Model 1600; Senior Solutions Shortwave Diathermy, Model 1601 through their predicates, nearest generation first.

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