510(k) Report

Devices descending from K984552

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K242789Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)Dongguan Laiguang Electronic Technology Co., Ltd.20253—
+8K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+8K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd.202412—
+8K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+8K240991eMVFit (MVF-10M)Weero Co., Ltd.20240—
+8K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+8K241656Eneka SelectifTermosalud20241—
+8K241203PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT…Dongguan Hunter Electronic Technology Co., Ltd.20240—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K233344Regenalase Laser SystemIpg Medical20240—
+8K233473Deka LotusEl.En S.P.A.20241—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K233962ReBorn (1050nm)Lightfective, Ltd.20240—
+8K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd.20242—
+8K233642InMode RF SystemInMode, Ltd.20244—
+8K232863Radiant Renewal Skincare Wand (HD-15, HD-15A)Shenzhen Kaiyan Medical Equipment Co., Ltd.20230—
+8K232236EchoQuanta System Spa20230—
+8K223919B.Light Clear Evo and B.Light Restore EvoBemer Int AG20232—
+8K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+8K222790F65 Laser SystemLumenis Be, Ltd.20233—
+8K230293TheraFace MaskTherabody, Inc.202316—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K223893Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V.20235—
+8K223805AgnesAgnes Medical Co., Ltd.20233—
+8K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.20239—
+8K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd.202339—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K222221Deka HelixEl.En Electronic Engineering Spa20231—
+8K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.20222—
+8K221444LED Eye Perfector, model: EY-36A, EY-36BLight Tree Ventures Europe B.V.20223—
+8K222377Led Mask Platinum MdCellreturn Co., Ltd.20224—
+8K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+8K214015Palm NRG cellulite body device (model: Palm NRG body device)Heat IN A Click, LLC20220—
+8K213674CellFX SystemPulse Biosciences, Inc.20220—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K222075CellFX SystemPulse Biosciences, Inc.20220—
+8K221671CellFX® SystemPulse Biosciences, Inc.20220—
+8K220064Synergy Marble (Model: Opasm)Yrs Group, Inc.20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K221407truSculpt iDCutera, Inc.20222—
+8K211652Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation20220—
+8K220592Venus BlissMAXVenus Concept USA, Inc.20221—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K214101Project E Beauty LED Light Therapy Mask (Model: PE730)Duplex International Trading Limited20220—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K213308Venus BlissMAXVenus Concept USA, Inc.20222—
+8K212155TheraFace LEDTheragun, Inc.202142—
+8K210965reVive Light Therapy EssentialsLed Technologies, Inc.20213—
+8K212275Dermalux Flex MDAesthetic Technology, Ltd.20214—
+8K212107ReversoIntelis Instruments, Ltd.20211—
+8K211461Family of Venus RF Systems - Venus FreedomVenus Concept USA, Inc.20210—
+8K212238TheraFace MicrocurrentTheragun, Inc.20210—
+8K210877Evolve System with the T3 ApplicatorInMode, Ltd.20215—
+8K202390Aduro Light Beauty MaskShenzhen Kaiyan Medical CO, Ltd.202139—
+8K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K201285InMode Evolve System with the Tone ApplicatorInMode, Ltd.20216—
+8K203665STOP U Model UXV DevicePollogen, Ltd.20214—
+8K202199BTL-899STBtl20216—
+8K193266MIINMedico USA, Inc.20210—
+8K202172StarWalkerFotona D.O.O.20203—
+8K201475Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20200—
+8K201406PicowonWontech Co., Ltd.20200—
+8K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K200241TempSure SystemCynosure, LLC202013—
+8K192430Epic 980Biolase, Inc.20195—
+8K191855EmFace DeviceInmode MD, Ltd.20191—
+8K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+8K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K190443MMSphereGalactic Beauty, LLC201942—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K181095RF-ReliefEl Global Trade, Ltd.20181—
+8K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+8K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K173199PicoSure WorkstationCynosure, Inc.20189—
+8K172302InMode PLUS SystemInmode MD, Ltd.201713—
+8K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+8K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+8K170984LG Beauty Led MaskLg Electronics201793—
+8K162755PicocareWontech Co., Ltd.20179—
+8K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+8K170500SIROLaser Advance+Dentsply Sirona201721—
+8K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+8K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—