510(k) Report

Devices descending from K013197

151 later devices reach WS-501 Heat Lamp through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050397Velasmooth, ShaperSyneron Medical, Ltd.2005150—
+2K090221Reaction SystemViora, Ltd.200954—
+2K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+2K082622Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd.200945—
+2K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+2K071872VelashapeSyneron Medical, Ltd.2007127—
+2K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+2K061603SmoothshapesBiocellulase, Inc.200648—
+2K053611SmoothshapesBicellulase, Inc.200695—
+3K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+3K173759Thermage CPT System and AccessoriesSolta Medical201821
+3K170758Thermage FLX System and AccessoriesSolta Medical201713—
+3K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+3K160075Accent XLAlma Lasers, Inc.20160—
+3K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+3K143554Venus Legacy CXVenus Concept, Ltd.201517—
+3K150035V10 systemViora, Ltd.201531—
+3K141904Viora V-TouchViora, Ltd.20140—
+3K133837Viora V-TotalViora, Ltd.201433—
+3K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+3K132431Thermage CPT SystemSolta Medical, Inc.2013171
+3K120510TranscendSyneron Medical, Ltd.201318—
+3K122579VelashapeSyneron Medical, Ltd.20124—
+3K101147Modified Alma Lasers Family of Accent Radiofrequency (RF) SystemAlma Lasers, Inc.20114—
+3K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+3K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+3K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+3K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+3K083629SmoothshapesEleme Medical, Inc.200927—
+4K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+4K261582Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+4K250852CoolfaseAsterasys Co., Ltd.20250—
+4K251327XERFLutronic Corporation202501
+4K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+4K242241SunnyShenB Co., Ltd.20250—
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240248Volnewmer™Classys, Inc.20241—
+4K23299210THERMATentech, Inc.20230—
+4K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221989The OligioWontech Co., Ltd.20222—
+4K212561MTX-C1Ilooda Co,., Ltd.20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K202780SectumNeauvia North America20211—
+4K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+4K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+4K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+4K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+4K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+4K190743Venus BlissVenus Concept USA, Inc.20194—
+4K183450EmBody SystemInmode MD, Ltd.20198—
+4K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+4K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+4K170637sensiFirmEl Global Trade, Ltd.20173—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K162512truSculptCutera, Inc.20165—
+4K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+4K161043Profound SystemSyneron Candela Corporation20160—
+4K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+4K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+4K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+4K153568InMode Plus SystemInmode MD, Ltd.201618—
+4K152611V20 systemViora, Ltd.20164—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K142093V20 SystemViora, Ltd.201432—
+4K123971Cynosure 1064NM Diode LaserCynosure, Inc.201325—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K111501I-Lipo SystemChromogenex Technologies Limited201215—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+5K251632Optimas MAX SystemInMode, Ltd.20251—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K240897CellinewVIOL Co., Ltd.20240—
+5K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+5K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+5K240313Oligio XWontech Co., Ltd.20241—
+5K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+5K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+5K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+5K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+5K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+5K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+5K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+5K192224BTL-899Btl20198—
+5K191855EmFace DeviceInmode MD, Ltd.20191—
+5K181095RF-ReliefEl Global Trade, Ltd.20181—
+5K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+5K172302InMode PLUS SystemInmode MD, Ltd.201713—
+5K172004truSculptCutera, Inc.20173—
+5K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+5K152731XP1100 RFBTL Industries, Inc.20160—
+5K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+5K150724SculpSureCynosure, Inc.201521—
+5K150230SculpSureCynosure, Inc.201521—
+5K143741Lipofina Laser SystemYolo Medical, Inc.20153—