510(k) Report

Devices descending from K984552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K232223PlaDuo SystemShenB Co., Ltd.20230—
+7K231495The Evolve System with the Transform ApplicatorInMode, Ltd.20231—
+7K231092T-Shape 2B&M S.R.L. Marketing Nel Benessere20230—
+7K231146AliTightAlic Iotech, LLC20230—
+7K230013Silk'n Titan AllwaysSilk'N Beauty, Ltd.20230—
+7K231555LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))iSMART Developments, Ltd.20231—
+7K231790The InMode System with the Morpheus8 ApplicatorsInMode, Ltd.202310—
+7K230077LaserMENeauvia North America20232—
+7K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V.202318—
+7K223138AB1 Electrosurgical Instrument, Creo Electrosurgical SystemCreo Medical, Ltd.20231—
+7K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+7K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+7K223147myLEDmaskMyblend20234—
+7K221672Creo Electrosurgical System with NP1 InstrumentCreo Medical, Ltd.20230—
+7K223680Eneka ProTermosalud20230—
+7K222685NIRA Model 2Dermal Photonics Corp20230—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K212561MTX-C1Ilooda Co,., Ltd.20220—
+7K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+7K221189Oliz LTB-1000ALtbio Co., Ltd.20220—
+7K221430reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.20220—
+7K203013AGNESAgnes Medical Co., Ltd.20224—
+7K221083Smartlux MiniMedmix Co., Ltd.20222—
+7K212472AgeJetTriworks Group Srl20220—
+7K220729The Luminance RED Acne DeviceLuminance Medical Ventures, Inc.20221—
+7K211000AcutronIlooda Co,., Ltd.20220—
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210545Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty…Marci Beauty, Inc.20222—
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K213534PHantom TrilogyResurgeonz, LLC20220—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K213814Viveve 2.0 SystemViveve, Inc.20220—
+7K213841ENEO TOTALE (Model: ENEOT947)Premier North America, Inc.20222—
+7K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+7K210847UltraClear Fractional Laser SystemFa International, LP20210—
+7K202288FinebeamSNJ Co., Ltd.20212—
+7K212607DarwinLuvo Medical Technologies, Inc.20210—
+7K211444CellFX SystemPulse Biosciences, Inc.20213—
+7K202780SectumNeauvia North America20211—
+7K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd.202146—
+7K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+7K211272ICOONE Laser Med (also referred to as ICOONE Medical laser)I-Tech Industries Srl20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K202055Looper (Model: ZX-579S)Heat IN A Click, LLC20213—
+7K202988Tixel SystemNovoxel, Ltd.20211—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K202028dermalux Flex MDAesthetic Technology, Ltd.20205—
+7K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+7K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+7K192295PDT-FaceBeijing Adss Development Co., Ltd.202046—
+7K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K191065Venus VivaTMVenus Concept USA, Inc.20200—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+7K191086ExciplexClarteis20194—
+7K192224BTL-899Btl20198—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K191942MT One DiamondM&T S.R.L.20191—
+7K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+7K190678TempSureCynosure, Inc.201914—
+7K190743Venus BlissVenus Concept USA, Inc.20194—
+7K183450EmBody SystemInmode MD, Ltd.20198—
+7K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+7K183247dpl FacewareLed Technologies, Inc.201910—
+7K183118dpl SpotLiteLed Technologies, Inc.201922—
+7K182094Family of Venus RF Systems - HealVenus Concept USA, Inc.20191—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+7K180875Poly RejuvMedtek Skincare, LLC20180—
+7K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845—
+7K180847Neutrogena Light Therapy Acne Mask+Johnson & Johnson Consumer, Inc.201844—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc.20183—
+7K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc.20185—
+7K1718212 Face / Face EvolutionHeat IN A Click201858—
+7K180396miraDry SystemMiramar Labs, Inc.20180—
+7K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+7K171262TempSureCynosure, Inc.201716—
+7K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+7K171227StarWalkerFotona D.O.O.20177—
+7K172004truSculptCutera, Inc.20173—
+7K170637sensiFirmEl Global Trade, Ltd.20173—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+7K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+7K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+7K162781Magma SparkFormatk Systems, Ltd.20160—
+7K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—