510(k) Report

Devices descending from K024064

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171702Exciplex308nmClarteis20175—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K162512truSculptCutera, Inc.20165—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K143559XP1000 RFBTL Industries, Inc.20157—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143109XP300BTL Industries, Inc.20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+6K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K130689Symphony RF GeneratorThermigen, Inc.201311—
+6K131839DC 7Dc International, LLC20130—
+6K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+6K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K111689StlaseDental Photonics, Inc.201222—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K253504Volnewmer™Classys, Inc.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+7K253750BTL-785NEHBTL Industries, Inc.20260—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+7K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K244022308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV…Boston Aesthetics, Inc.20250—
+7K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd.20253—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K243139Reverso Pro SystemIndiba S. A. U.20250—
+7K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253—
+7K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+7K242532BTL-785BNF-EBTL Industries, Inc.20241—
+7K240897CellinewVIOL Co., Ltd.20240—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—