510(k) Report

Devices descending from K024064

681 later devices reach Polaris DS through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K122966XP200Btl Industries, Ltd.20131—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+5K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K102698Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve GlidesafeEllman Int'L, Inc.201139—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K094049Stlase Diode LaserDental Photonics, Inc.201023—
+5K102368Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc.201052—
+5K092195Cutera Multimodal Cellulite Product (Cmmcd)Cutera, Inc.20090—
+5K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919—
+5K083733Lume 2 System, Model GA0005000Lumenis, Ltd.200939—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+5K081408Ellipse MultiflexEllipse A/S20087—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K250852CoolfaseAsterasys Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251327XERFLutronic Corporation202501
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251632Optimas MAX SystemInMode, Ltd.20251—
+6K240857Youmagic FLM System (YM5-U1)We Medical Technology (Wuxi) Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K242241SunnyShenB Co., Ltd.20250—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243488Vmat ProTermosalud20250—
+6K240311JETT Medical IICompex, Spol, S.R.O.20250—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K242688Finiff SystemSkingrab Co., Ltd.20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240248Volnewmer™Classys, Inc.20241—
+6K233849BTL-499BTL Industries, Inc.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K233604BTL-785SBTL Industries, Inc.20243—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K23299210THERMATentech, Inc.20230—
+6K231146AliTightAlic Iotech, LLC20230—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K230663DensityJeisys Medical, Inc.20232—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K223680Eneka ProTermosalud20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K221989The OligioWontech Co., Ltd.20222—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K193266MIINMedico USA, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K192430Epic 980Biolase, Inc.20195—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K191528Venus Legacy Pro DeviceVenus Concept USA, Inc.20193—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901