510(k) Report

Devices descending from K800617

1,325 later devices reach Hyfrecator, #733 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+7K230968VYBE RF Electrosurgical SystemShenB Co., Ltd.20231—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+7K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K221873NeoGen PSR SystemEnergist Limited20230—
+7K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+7K222701MANTA LaserSqualus Med, Ltd.20222—
+7K22079410PLTentech Co., Ltd.20220—
+7K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+7K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+7K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+7K212790XLase PlusBiotec Italia, Srl20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K213612Sylfirm XVIOL Co., Ltd.20221—
+7K210084SilkroHironic Co., Ltd.20223—
+7K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+7K213594Echolaser X4Elesta S.P.A20221—
+7K210183Waterlase iPLusBiolase, Inc.20220—
+7K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+7K211562Virtue RFShenB Co., Ltd.20212—
+7K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+7K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+7K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation2021313
+7K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+7K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+7K202955Contour Light CL-100Contour Research, LLC20218—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K203299CellFX SystemPulse Biosciences, Inc.20214—
+7K201685PotenzaJeisys Medical, Inc.20219—
+7K201735PlaDuo SystemShenB Co., Ltd.20203—
+7K192275invisa-RED ELITEIR Technology, LLC20201—
+7K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+7K200616E>EyeCE-Swin20200—
+7K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+7K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp.20204—
+7K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+7K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+7K193367elysion-proHigh Technology Products S.L.U20203—
+7K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+7K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+7K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+7K192728AgnesAgnes Medical Co., Ltd.20196—
+7K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+7K190610Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologySterilmed, Inc.20190—
+7K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+7K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+7K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+7K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K182365TempSure SystemCynosure, Inc.201815—
+7K180338CellulizeWard Photonics, LLC20182—
+7K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+7K181659Avologi ENEOPremier North America, Inc.20184—
+7K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+7K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+7K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+7K180508Joule SystemSciton, Inc20183—
+7K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+7K180320dpl IIa PanelLed Technologies, Inc.201814—
+7K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+7K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+7K172111Vevazz LEDVevazz, LLC20170—
+7K172535Bipolar applicator CELON ProCurve VOlympus Winter & Ibe GmbH20170—
+7K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+7K171702Exciplex308nmClarteis20175—
+7K172413MT ONEM&T S.R.L.20175—
+7K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+7K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+7K171227StarWalkerFotona D.O.O.20177—
+7K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+7K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+7K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+7K163196ACTION II Laser SystemLutronic Corporation20170—
+7K170908PK AIMGyrus Acmi, Inc.20170—
+7K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+7K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+7K163415SlimShape SystemSyneron Medical, Ltd.201714—
+7K170456Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue TechnologyStryker Sustainability Solutions201701
+7K162784Silk'n HSTHome Skinovations, Ltd.20171—
+7K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+7K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+7K161949OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20177—
+7K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+7K162512truSculptCutera, Inc.20165—
+7K161825PK AIMGyrus Acmi, Inc.20162—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+7K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc.201661
+7K153566Magma SystemFormatk Systems, Ltd.20162—
+7K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC20164—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152280BioPhotas Celluma3Biophotas, Inc.201649—
+7K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—