510(k) Report

Devices descending from K800617

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K192856MT OneM&T S.R.L.20202—
+6K200185Sylfirm XVIOL Co., Ltd.20202—
+6K193656SkyPulseFotona D.O.O.202011—
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K183284INTRAcel RF Microneedle SystemJeisys Medical, Inc.20200—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K191693BC-5Reveallux, Corp20190—
+6K191073Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterVein 360, LLC20190—
+6K183708Poly ClearMedtek Skincare, LLC201922—
+6K190938Phototherapy SystemShanghai Apolo Medical Technology Co., Ltd.201916—
+6K190422Viveve System 2.0Viveve Medical20194—
+6K181510Echolaser X4El.En Electronic Engineering Spa20183—
+6K180900LED Light Therapy DeviceUvbiotek, LLC201829—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K173285Joule SystemSciton, Inc20185—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K171055Philips BlueControlPhilips Electronics Nederland B.V.20171—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+6K160469AGNESGowoonsesang Cosmetics Co., Ltd.20179—
+6K161941Pulsaderm Acne DeviceNutra Luxe MD, LLC20164—
+6K161038PK MorcellatorGyrus Acmi, Inc.20160—
+6K160880Photonica ProfessionalWard Photonics, LLC20166—
+6K160075Accent XLAlma Lasers, Inc.20160—
+6K153229SuperbiumBios S.R.L.20162—
+6K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp.20166—
+6K152702Ent Biotech Solutions Tissue Removal Device (Elasso)Ent Biotech Solutions20160—
+6K153081Clear Bi-LightMichael Todd, LP201646—
+6K152057OsteoCool V-3 RF Ablation SystemBaylis Medical Company, Inc.20158—
+6K134036Wavetronic 5000 Digital HF Surgical UnitLoktal Medical Electronics Ind. Com. Ltda- Epp20150—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+6K140386Lumina 24Rogers Sciences, Inc.20150—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143109XP300BTL Industries, Inc.20150—
+6K142860Lumenis M22 SystemLumenis, Ltd.2015381
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142350PK J-HookGyrus Acmi, Inc.201511
+6K142256Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd.20150—
+6K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+6K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+6K142340Infrared Therapy SystemBeijing Huatai Healthcare Technology Co., Ltd.20140—
+6K142525PK Lap LoopOlympus Winter & Ibe GmbH20140—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K124033Medisiss Reprocessed Ultrasonic InstrumentsSurgical Instruments Service and Savings, Inc.20140—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC20139—
+6K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013112—
+6K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+6K131205Arthrocare Head and Neck Coblation WandArthroCare Corporation20130—
+6K130305Lina Bipolar Loop; Standard Size, Large Size, Extra Large SizeLina Medical Aps20130—
+6K120510TranscendSyneron Medical, Ltd.201318—
+6K123366Surgitron 4.0 Dual RF S5-IecEllman International, Inc.2013161
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121435Silkn BlueHome Skinovations, Ltd.2013125—
+6K122237Biophotas LifelightBiophotas, Inc.201371—
+6K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+6K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+6K122605PKS BillGyrus Acmi, Inc.20121—
+6K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+6K120513Glow by EndymedEndymed Medical, Ltd.20125—
+6K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+6K111670Venus Freeze (MP)2 SystemVenus Concept, Ltd.201213—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K111286Quasar CalypsoSilver Bay, LLC201276—
+6K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K111026ApolloPollogen, Ltd.201114—
+6K111784Venus Swan SystemVenus Concept, Ltd.20111—
+6K110672Etwo Skin Treatment SystemSyneron, Ltd.20112—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K111887Closurefast Radiofrequency CatheterCovidien20116—
+6K110301Silk'n FXHome Skinovations, Ltd.201166—
+6K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+6K102461FractoraInvasix, Ltd.201124—
+6K103775Peak Suction CoagulatorPeak Surgical, Inc.20111—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K102366Finess EndoscopeEntellus Medical, Inc.20110—
+6K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+6K103415Tanda MaxPharos Life Corporation20110—
+6K102709Peak Plasmablade Plus Tissue Dissection DevicePeak Surgical, Inc.20100—
+6K100628PlasmaluxlsDaavlin Distributing Co.20100—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K091467Baby QuasarSilver Bay, LLC20100—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K090661Nes Reprocessed Varicose Vein RF CatheterNortheast Scientific, Inc.20100—
+6K100896Gyrus Acmi Halo PKS Cutting ForcepsGyrus Acmi, Inc.201031
+6K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+6K090744CLAROClrs Technology Corporation20101—