510(k) Report

Devices descending from K984552

1,174 later devices reach Cool-Tip RF System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K220472NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20221—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K213612Sylfirm XVIOL Co., Ltd.20221—
+6K212871Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) ElectrodeGalvanize Therapeutics, Inc.20222—
+6K210084SilkroHironic Co., Ltd.20223—
+6K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+6K211562Virtue RFShenB Co., Ltd.20212—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+6K201265Disposable Microwave Therapeutic AntennasNanjing Eco Microwave System Co., Ltd.20214—
+6K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K201262Microwave Therapeutic SystemNanjing Eco Microwave System Co., Ltd.20214—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+6K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+6K202955Contour Light CL-100Contour Research, LLC20218—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K203299CellFX SystemPulse Biosciences, Inc.20214—
+6K201685PotenzaJeisys Medical, Inc.20219—
+6K200298ABI Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20212—
+6K203303Emprint SX Ablation Platform with Thermosphere TechnologyCovidien, LLC20200—
+6K201735PlaDuo SystemShenB Co., Ltd.20203—
+6K200003NP1 Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20201—
+6K200796Emprint Ablation System with Thermosphere TechnologyCovidien, LLC20203—
+6K192275invisa-RED ELITEIR Technology, LLC20201—
+6K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+6K200616E>EyeCE-Swin20200—
+6K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+6K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+6K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+6K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+6K192728AgnesAgnes Medical Co., Ltd.20196—
+6K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+6K182365TempSure SystemCynosure, Inc.201815—
+6K180338CellulizeWard Photonics, LLC20182—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K181659Avologi ENEOPremier North America, Inc.20184—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+6K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+6K180508Joule SystemSciton, Inc20183—
+6K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+6K180320dpl IIa PanelLed Technologies, Inc.201814—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172111Vevazz LEDVevazz, LLC20170—
+6K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+6K171702Exciplex308nmClarteis20175—
+6K172413MT ONEM&T S.R.L.20175—
+6K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+6K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K162784Silk'n HSTHome Skinovations, Ltd.20171—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+6K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+6K162512truSculptCutera, Inc.20165—
+6K160141miraDry SystemMiramar Labs, Inc.20161—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K152280BioPhotas Celluma3Biophotas, Inc.201649—
+6K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+6K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+6K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K143554Venus Legacy CXVenus Concept, Ltd.201517—
+6K143559XP1000 RFBTL Industries, Inc.20157—
+6K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+6K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+6K150035V10 systemViora, Ltd.201531—
+6K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K140471Pro X Otc 5La Lumiere, LLC2015107—
+6K142910Legacy BXVenus Concept USA, Inc.201411—
+6K141904Viora V-TouchViora, Ltd.20140—
+6K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+6K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+6K140629Venus Swan (MP)2Venus Concept, Ltd.20140—
+6K140255Stop U (Packed Black Usa); Stop U (Packed White Usa)Pollogen, Ltd.20147—
+6K133837Viora V-TotalViora, Ltd.201433—
+6K131113Biophotas CellumaBiophotas, Inc.201455—
+6K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—