510(k) Report

Devices descending from K050397

150 later devices reach Velasmooth, Shaper through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090221Reaction SystemViora, Ltd.200954—
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+1K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+1K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+1K071872VelashapeSyneron Medical, Ltd.2007127—
+1K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+1K061603SmoothshapesBiocellulase, Inc.200648—
+1K053611SmoothshapesBicellulase, Inc.200695—
+2K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+2K173759Thermage CPT System and AccessoriesSolta Medical201821
+2K170758Thermage FLX System and AccessoriesSolta Medical201713—
+2K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+2K160075Accent XLAlma Lasers, Inc.20160—
+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—
+2K132431Thermage CPT SystemSolta Medical, Inc.2013171
+2K120510TranscendSyneron Medical, Ltd.201318—
+2K122579VelashapeSyneron Medical, Ltd.20124—
+2K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+2K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+2K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+2K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+2K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+2K083629SmoothshapesEleme Medical, Inc.200927—
+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—
+3K250852CoolfaseAsterasys Co., Ltd.20250—
+3K251327XERFLutronic Corporation202501
+3K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+3K242241SunnyShenB Co., Ltd.20250—
+3K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+3K242688Finiff SystemSkingrab Co., Ltd.20240—
+3K240248Volnewmer™Classys, Inc.20241—
+3K23299210THERMATentech, Inc.20230—
+3K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+3K230663DensityJeisys Medical, Inc.20232—
+3K221989The OligioWontech Co., Ltd.20222—
+3K212561MTX-C1Ilooda Co,., Ltd.20220—
+3K221571InMode Multi-systemInMode, Ltd.20222—
+3K202780SectumNeauvia North America20211—
+3K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+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—
+3K163415SlimShape SystemSyneron Medical, Ltd.201714—
+3K162512truSculptCutera, Inc.20165—
+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—
+3K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+3K153568InMode Plus SystemInmode MD, Ltd.201618—
+3K152611V20 systemViora, Ltd.20164—
+3K143559XP1000 RFBTL Industries, Inc.20157—
+3K142093V20 SystemViora, Ltd.201432—
+3K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+3K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+3K111501I-Lipo SystemChromogenex Technologies Limited201215—
+4K253504Volnewmer™Classys, Inc.20260—
+4K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+4K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+4K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+4K251632Optimas MAX SystemInMode, Ltd.20251—
+4K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+4K240897CellinewVIOL Co., Ltd.20240—
+4K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+4K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+4K240313Oligio XWontech Co., Ltd.20241—
+4K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+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—
+4K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+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—
+4K192224BTL-899Btl20198—
+4K191855EmFace DeviceInmode MD, Ltd.20191—
+4K181095RF-ReliefEl Global Trade, Ltd.20181—
+4K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+4K172302InMode PLUS SystemInmode MD, Ltd.201713—
+4K172004truSculptCutera, Inc.20173—
+4K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+4K152731XP1100 RFBTL Industries, Inc.20160—
+4K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+4K150724SculpSureCynosure, Inc.201521—
+4K150230SculpSureCynosure, Inc.201521—
+4K143741Lipofina Laser SystemYolo Medical, Inc.20153—
+4K130341Strawberry, Strawberry & CreamLaser Lipo Limited201312—