510(k) Report

Devices descending from K031671

678 later devices reach Polaris WR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+4K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+4K242688Finiff SystemSkingrab Co., Ltd.20240—
+4K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240248Volnewmer™Classys, Inc.20241—
+4K233849BTL-499BTL Industries, Inc.20240—
+4K233604BTL-785SBTL Industries, Inc.20243—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K23299210THERMATentech, Inc.20230—
+4K231146AliTightAlic Iotech, LLC20230—
+4K230663DensityJeisys Medical, Inc.20232—
+4K221865BTL-094BTL Industries, Inc.20230—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K210166Omnispec ED1000Medispec, Ltd.20230—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221989The OligioWontech Co., Ltd.20222—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+4K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+4K192856MT OneM&T S.R.L.20202—
+4K191065Venus VivaTMVenus Concept USA, Inc.20200—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192545PotenzaJeisys Medical Incorporated202020—
+4K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K173503Pollogen Legend SystemPollogen, Ltd.20183—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K172096FraxisIlooda Co,., Ltd.20172—
+4K170325Secret RFIlooda Co,., Ltd.201710—
+4K163415SlimShape SystemSyneron Medical, Ltd.201714—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K162512truSculptCutera, Inc.20165—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K153717Venus Versa SystemVenus Concept, Ltd.20161—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K143559XP1000 RFBTL Industries, Inc.20157—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K143109XP300BTL Industries, Inc.20150—
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K130689Symphony RF GeneratorThermigen, Inc.201311—
+4K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090762LEDAQuantel Derma GmbH200946—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K253504Volnewmer™Classys, Inc.20260—
+5K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K253750BTL-785NEHBTL Industries, Inc.20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—