510(k) Report

Devices descending from K984552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+5K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+5K103415Tanda MaxPharos Life Corporation20110—
+5K100628PlasmaluxlsDaavlin Distributing Co.20100—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K091467Baby QuasarSilver Bay, LLC20100—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K090744CLAROClrs Technology Corporation20101—
+5K092460Star-Lite -LM, Model SL8809Ps Advanced Engineering20101—
+5K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC201011—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+5K083183Aklarus Phototherapy SystemHill Laboratories Co.200991—
+5K090221Reaction SystemViora, Ltd.200954—
+5K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+5K090525Loi SystemPalomar Medical Products, Inc.20099—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K081408Ellipse MultiflexEllipse A/S20087—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080300Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.2008101—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+5K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+5K072394Portrait Stand-OffRhytec Incorporated2007104—
+5K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+5K071872VelashapeSyneron Medical, Ltd.2007127—
+5K070092Modification to Velasmooth, ShaperSyneron Medical, Ltd.2007128—
+5K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+5K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+5K061603SmoothshapesBiocellulase, Inc.200648—
+5K053611SmoothshapesBicellulase, Inc.200695—
+5K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+5K052324Polaris LV, Lva ApplicatorSyneron Medical, Ltd.2005456—
+5K051681Dermillume Red, Model HR1000Care Electronics, Inc.20053—
+5K041969Aurora DSSyneron Medical, Ltd.2004302—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K262364Ellian Enigma RF DeviceEllian Corp20260—
+6K253846Steep Pulse Ablation Instrument (including Disposable Sterile Steep Pulse Probe)…Hangzhou Ruidi Biotechnology, Ltd.20260—
+6K253504Volnewmer™Classys, Inc.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K253750BTL-785NEHBTL Industries, Inc.20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K254290ZenTite (Unicorn+); ZenTite (Unicorn+I); ZenTite (Unicorn+II); ZenTite (Unicorn+III)Shenzhen Peninsula Medical Group20260—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+6K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K250224handLITE (TN19S)iSMART Developments, Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+6K243488Vmat ProTermosalud20250—
+6K240311JETT Medical IICompex, Spol, S.R.O.20250—
+6K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K242532BTL-785BNF-EBTL Industries, Inc.20241—
+6K242687NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15…AngioDynamics, Inc.20241—
+6K240897CellinewVIOL Co., Ltd.20240—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K231948MediyagMedicreations, LLC20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K233120CWM-930S, Fixer DV9Chungwoo Co., Ltd.20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K232301Define RF Microneedling SystemAesthetic Management Partners20240—
+6K240313Oligio XWontech Co., Ltd.20241—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+6K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+6K222001Irreversible Electroporation Ablation Generator, Irreversible Electroporation ProbeZhejiang Curaway Medical Technology Co., Ltd.20230—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K221873NeoGen PSR SystemEnergist Limited20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K22079410PLTentech Co., Ltd.20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—