510(k) Report

Devices descending from K013028

906 later devices reach Palomar SLP 1000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd.20195—
+6K183260Sensilight Pro / Pistol IPLEl Global Trade, Ltd.20190—
+6K183217IPL Hair Removal DeviceTouchbeauty Beauty & Health (Shenzhen) Co., Ltd.20193—
+6K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+6K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K173813IPL Hair Removal Device Joy VersionShen Zhen Cosbeauty Co., Ltd.201836—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180383Light based hair removal deviceShenzhen Gsd Tech Co., Ltd.20181—
+6K180016Home Use IPL Beauty DeviceShenzhen Mismon Technology Co., Ltd.201825—
+6K172883Home Use Hair Removal Device/T1, T2, T3Shenzhen Mareal Tech Co., Ltd.20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171227StarWalkerFotona D.O.O.20177—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017115—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162512truSculptCutera, Inc.20165—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+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—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+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—
+6K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K133201Shaser V-Mini 2 Hair Removal SystemShaser, Inc.201496—
+6K130689Symphony RF GeneratorThermigen, Inc.201311—
+6K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+6K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K092734E-Light LineEspansione Marketing S.P.A20102—
+6K094049Stlase Diode LaserDental Photonics, Inc.201023—
+6K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+6K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K261705Hair Removal Device (R3C16-G Pro, R3C16-V Pro)Shenzhen Jianchao Intelligent Technology Co., Ltd.20260—
+7K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.20260—
+7K253504Volnewmer™Classys, Inc.20260—
+7K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.20260—
+7K261325Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+7K260518IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2…Shenzhen Semlamp Intelligent Technology Co., Ltd.20260—
+7K253750BTL-785NEHBTL Industries, Inc.20260—
+7K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+7K253304IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)Dongguan Lide Electric Appliance Co., Ltd.20250—
+7K253035IPL Hair Removal Device (SYL001AZ, SYL002AZ)Gu'An Yeolight Smart Electronics Co., Ltd.20250—
+7K252845Venus Nova (FP-2001)Venus Concept, Inc.20250—
+7K252209IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)Foshan Jindi Electric Appliance Co., Ltd.20251—
+7K251457Diode laser therapy device (VADER)Beijing Superlaser Technology Co., Ltd.20250—
+7K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+7K251176IPL Hair Removal Device (Model (s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B…Shenzhen Mlay Intelligent Technology Co.,, Ltd.20251—
+7K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+7K251984Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU…Shenzhen Ulike Smart Electronics Co., Ltd.20250—
+7K250065DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated20250—
+7K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250194Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH)Shenzhen Ulike Smart Electronics Co., Ltd.20252—
+7K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—