510(k) Report

Devices descending from K850668

1,030 later devices reach Electrosurgical Unit 774 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+8K231894LED Spectrum therapy instrumentShenzhenshi Sincoheren S&T Development Co., Ltd.20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+8K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+8K22079410PLTentech Co., Ltd.20220—
+8K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+8K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd.20224—
+8K210183Waterlase iPLusBiolase, Inc.20220—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+8K212771LightStim ElipsaLed Intellectual Properties, LLC20221—
+8K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+8K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd.202121—
+8K203728DarwinLuvo Medical Technologies, Inc.20211—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K210535UltraLight LED SystemRohrer Aesthetics, LLC20210—
+8K202955Contour Light CL-100Contour Research, LLC20218—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202172StarWalkerFotona D.O.O.20203—
+8K192621Medical RFTriworks Group Srl20200—
+8K192275invisa-RED ELITEIR Technology, LLC20201—
+8K200616E>EyeCE-Swin20200—
+8K200751Photodynamic Therapy (PDT) EquipmentShangdong Huamei Technology Co., Ltd.20201—
+8K200659Dermalux Tri-Wave MDAesthetic Technology, Ltd.20203—
+8K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K193367elysion-proHigh Technology Products S.L.U20203—
+8K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+8K192755Soli-Lite LG4 GalileoSilhouet-Tone Corporation20193—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+8K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+8K183156V-LaserWontech Co., Ltd.20193—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+8K180338CellulizeWard Photonics, LLC20182—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+8K181659Avologi ENEOPremier North America, Inc.20184—
+8K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+8K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc.201835—
+8K180508Joule SystemSciton, Inc20183—
+8K172555Sapphire, Elevare SapphireOmm Imports, Inc. D/B/A Zero Gravity201852—
+8K180320dpl IIa PanelLed Technologies, Inc.201814—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc.201844
+8K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+8K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+8K172111Vevazz LEDVevazz, LLC20170—
+8K162652Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation201710—
+8K171702Exciplex308nmClarteis20175—
+8K172413MT ONEM&T S.R.L.20175—
+8K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies20173—
+8K170187Photodynamic Therapy DeviceUvbiotek, LLC20170—
+8K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K163196ACTION II Laser SystemLutronic Corporation20170—
+8K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+8K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+8K162784Silk'n HSTHome Skinovations, Ltd.20171—
+8K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+8K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation201775—
+8K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc.201751
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K152737Lite TouchFocus Medical, LLC20160—
+8K152280BioPhotas Celluma3Biophotas, Inc.201649—
+8K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+8K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+8K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+8K152714Quanta ForteQuanta System Spa201513—
+8K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+8K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+8K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+8K140471Pro X Otc 5La Lumiere, LLC2015107—
+8K141507Two Skin Treatment SystemSyneron Medical, Ltd.20140—
+8K140926Inmode Wmface DeviceInmode MD, Ltd.20143—
+8K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+8K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+8K133405MinnieElettronica Valseriana Srl20140—
+8K133837Viora V-TotalViora, Ltd.201433—
+8K130501IntensifEndymed Medical, Ltd.201457—
+8K131113Biophotas CellumaBiophotas, Inc.201455—
+8K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+8K131839DC 7Dc International, LLC20130—
+8K130459Tria Fan SystemTria Beauty, Inc.20131—
+8K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+8K132431Thermage CPT SystemSolta Medical, Inc.2013171
+8K130793Newa Skin Therapy SystemEndymion Medical, Ltd.20130—
+8K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+8K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—