510(k) Report

Devices descending from K950239

1,329 later devices reach Sensimatic 500SE through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K210084SilkroHironic Co., Ltd.20223—
+9K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+9K210183Waterlase iPLusBiolase, Inc.20220—
+9K213350mJOULE System and AccessoriesSciton, Inc20220—
+9K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+9K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+9K211562Virtue RFShenB Co., Ltd.20212—
+9K212301Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection DeviceCovidien, LLC20210—
+9K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+9K212678Viveve System, Viveve 2.0 SystemViveve Medical, Inc.20211—
+9K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+9K203728DarwinLuvo Medical Technologies, Inc.20211—
+9K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+9K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+9K202955Contour Light CL-100Contour Research, LLC20218—
+9K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+9K203788DermaV Laser SystemLutronic Corporation202101
+9K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+9K203299CellFX SystemPulse Biosciences, Inc.20214—
+9K201685PotenzaJeisys Medical, Inc.20219—
+9K201735PlaDuo SystemShenB Co., Ltd.20203—
+9K202172StarWalkerFotona D.O.O.20203—
+9K201472VenSure Balloon Device, VenSure Nav Balloon DeviceFiagon GmbH20201—
+9K192275invisa-RED ELITEIR Technology, LLC20201—
+9K200947InMode System with the Morhpeus8 ApplicatorsInMode, Ltd.202015—
+9K200616E>EyeCE-Swin20200—
+9K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+9K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+9K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+9K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+9K193367elysion-proHigh Technology Products S.L.U20203—
+9K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+9K193611Viveve 2.0 SystemViveve Medical, Inc.20202—
+9K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+9K192728AgnesAgnes Medical Co., Ltd.20196—
+9K182355Secret RF Smartcure Applicator with electrodesIlooda Co,., Ltd.20191—
+9K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+9K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+9K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+9K190525RELIEVA ULTIRRA Sinus Balloon CatheterAcclarent, Inc.20190—
+9K183156V-LaserWontech Co., Ltd.20193—
+9K182453ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)I-Tech Industries Srl20192—
+9K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+9K182365TempSure SystemCynosure, Inc.201815—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K180338CellulizeWard Photonics, LLC20182—
+9K181518Sebacia MicroparticlesSebacia, Inc.20180—
+9K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+9K181659Avologi ENEOPremier North America, Inc.20184—
+9K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+9K180654PINXEL-RF systemRohrer Aesthetics, LLC20183—
+9K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+9K180508Joule SystemSciton, Inc20183—
+9K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+9K180320dpl IIa PanelLed Technologies, Inc.201814—
+9K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+9K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+9K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+9K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+9K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited20170—
+9K172111Vevazz LEDVevazz, LLC20170—
+9K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+9K171702Exciplex308nmClarteis20175—
+9K172413MT ONEM&T S.R.L.20175—
+9K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+9K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+9K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+9K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+9K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+9K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+9K163196ACTION II Laser SystemLutronic Corporation20170—
+9K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+9K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+9K163415SlimShape SystemSyneron Medical, Ltd.201714—
+9K162784Silk'n HSTHome Skinovations, Ltd.20171—
+9K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+9K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+9K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+9K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+9K162512truSculptCutera, Inc.20165—
+9K161698Relieva UltirraNav Sinus Balloon CatheterAcclarent, Inc.20161—
+9K161185LUCERNA Dental LaserViax Dental Lab20160—
+9K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+9K152737Lite TouchFocus Medical, LLC20160—
+9K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+9K153566Magma SystemFormatk Systems, Ltd.20162—
+9K152280BioPhotas Celluma3Biophotas, Inc.201649—
+9K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+9K153341Relieva Scout Multi-Sinus Dilation SystemAcclarent, Inc.20160—
+9K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+9K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+9K152714Quanta ForteQuanta System Spa201513—
+9K152121NuVent EM Sinus Dilation SystemMedtronic Xomed, Inc.20150—
+9K143738DSS Sinusplasty Balloon CatheterIntuit Medical Products, LLC20150—
+9K143554Venus Legacy CXVenus Concept, Ltd.201517—
+9K143559XP1000 RFBTL Industries, Inc.20157—
+9K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+9K150161Venus Viva SR DeviceVenus Concept, Ltd.20159—
+9K150035V10 systemViora, Ltd.201531—
+9K143541Relieva SpinPlus Balloon Sinuplasty SystemAcclarent, Inc.20152—