510(k) Report

Devices descending from K984552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+5K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+5K242688Finiff SystemSkingrab Co., Ltd.20240—
+5K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+5K240248Volnewmer™Classys, Inc.20241—
+5K233849BTL-499BTL Industries, Inc.20240—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K233838Emprint Ablation System with Thermosphere Technology (Overall System Name); Emprint…Medtronic, Inc.20240—
+5K233604BTL-785SBTL Industries, Inc.20243—
+5K232072Amica-Gen Agn-H-1.3, Amica-Gen Agn 3.3, Amica-Probe 17G & 18GH.S Hospital Service S.P.A20240—
+5K233024Alma HarmonyAlma Lasers, Inc.20241—
+5K23299210THERMATentech, Inc.20230—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K230663DensityJeisys Medical, Inc.20232—
+5K230308Alma HarmonyAlma Lasers, Inc.20232—
+5K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K221989The OligioWontech Co., Ltd.20222—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K193070VIVACE Electrosurgical DeviceShenB Co., Ltd.20214—
+5K203054FlexSysGme German Medical Engineering GmbH20210—
+5K202415VirtueRFShenB Co., Ltd.20213—
+5K202361UltraSlim Digital, UltraSmooth DigitalWard Photonics, LLC20200—
+5K200472Viveve SystemViveve Medical, Inc.20202—
+5K200081NEUWAVE Microwave Ablation System and AccessoriesNeuwave Medical, Inc.20202—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K200061HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1…Galil Medical, Inc.20200—
+5K192856MT OneM&T S.R.L.20202—
+5K200185Sylfirm XVIOL Co., Ltd.20202—
+5K193656SkyPulseFotona D.O.O.202011—
+5K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K193232Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with…Covidien, LLC20204—
+5K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+5K191693BC-5Reveallux, Corp20190—
+5K183708Poly ClearMedtek Skincare, LLC201922—
+5K183153Microwave Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.20199—
+5K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+5K183385NanoKnife SystemAngiodynamics201971
+5K190422Viveve System 2.0Viveve Medical20194—
+5K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+5K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173285Joule SystemSciton, Inc20185—
+5K171358Emprint SX Ablation Platform and AccessoriesCoviden, LLC20176—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+5K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+5K163105Emprint Ablation SystemCovidien, LLC2016133
+5K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+5K160880Photonica ProfessionalWard Photonics, LLC20166—
+5K160075Accent XLAlma Lasers, Inc.20160—
+5K153229SuperbiumBios S.R.L.20162—
+5K153081Clear Bi-LightMichael Todd, LP201646—
+5K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150419miraDry System MD4000Miramar Labs, Inc.201521
+5K140386Lumina 24Rogers Sciences, Inc.20150—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143109XP300BTL Industries, Inc.20150—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+5K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+5K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+5K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+5K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+5K120510TranscendSyneron Medical, Ltd.201318—
+5K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+5K122200A3F FrationalPollogen, Ltd.20130—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121435Silkn BlueHome Skinovations, Ltd.2013125—
+5K122237Biophotas LifelightBiophotas, Inc.201371—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K120513Glow by EndymedEndymed Medical, Ltd.20125—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+5K111286Quasar CalypsoSilver Bay, LLC201276—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K111026ApolloPollogen, Ltd.201114—
+5K111784Venus Swan SystemVenus Concept, Ltd.20111—
+5K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+5K110301Silk'n FXHome Skinovations, Ltd.201166—
+5K102461FractoraInvasix, Ltd.201124—