510(k) Report

Devices descending from K950019

1,568 later devices reach Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170500SIROLaser Advance+Dentsply Sirona201721—
+7K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37Pulsaderm, LLC201745—
+7K170068Softcure 96Wellray Medical Laser, Inc.20170—
+7K170260BC-001+ Acne PurifierOriental Inspiration Limited20172—
+7K163415SlimShape SystemSyneron Medical, Ltd.201714—
+7K162784Silk'n HSTHome Skinovations, Ltd.20171—
+7K161428PerfectSmoothShen Zhen Cosbeauty Co., Ltd.2017115—
+7K161892Slimming Treatment DeviceBeijing Honkon Technologies Co., Ltd.20171—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+7K162512truSculptCutera, Inc.20165—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K161286IPL Therapy MachineBeijing Adss Development Co., Ltd.20165—
+7K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+7K160821Tria SapphireTria Beauty, Inc.20160—
+7K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+7K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity201661—
+7K152611V20 systemViora, Ltd.20164—
+7K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+7K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+7K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+7K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+7K143713Lustre PRO Light SystemAmbicare Health, Ltd.20162—
+7K152889Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean PlusBiorenew Labs, LLC20153—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+7K151629Guardian 1000Quanta System Spa20150—
+7K143554Venus Legacy CXVenus Concept, Ltd.201517—
+7K150724SculpSureCynosure, Inc.201521—
+7K143559XP1000 RFBTL Industries, Inc.20157—
+7K150282Shaser Skin Beauty Intense Pulsed Light System Family for AcneShaser, Inc.20150—
+7K150230SculpSureCynosure, Inc.201521—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+7K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510—
+7K150051ExiliteBTL Industries, Inc.20150—
+7K150027CYMAWhitecap Technologies, LLC20150—
+7K143109XP300BTL Industries, Inc.20150—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K141986Elux 810 LaserEquipmed North America, Inc.20150—
+7K140471Pro X Otc 5La Lumiere, LLC2015107—
+7K140668Platinumgmt Ipl System CloudGlobal Medical Technology S.L.20142—
+7K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K141904Viora V-TouchViora, Ltd.20140—
+7K140120EPIC 10Biolase, Inc.20141—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+7K133546Starlite-OM, Light Effects, ThibiantPs Advanced Engineering20140—
+7K141583Shaser Skin Beauty Intense Pulsed Light System FamilyShaser, Inc.20142—
+7K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+7K133774AtovenBio-Med USA, Inc.20146—
+7K140631Lumena FH Hair Removal SystemShaser, Inc.201495—
+7K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+7K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+7K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+7K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+7K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC201481—
+7K130689Symphony RF GeneratorThermigen, Inc.201311—
+7K131362Inmode Wmbody DeviceInmode MD, Ltd.201317—
+7K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+7K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+7K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+7K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+7K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+7K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+7K121327Diolase 10SBiolase Technology, Inc.20132—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K122579VelashapeSyneron Medical, Ltd.20124—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+7K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+7K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+7K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd.201016—
+7K094049Stlase Diode LaserDental Photonics, Inc.201023—
+7K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100—
+7K100230Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc.201026—
+7K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+7K083629SmoothshapesEleme Medical, Inc.200927—
+7K081570DPL Therapy SystemLed Technologies, LLC200811
+7K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+7K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+7K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+7K070690The Life VesselCottonwood Vessel Corporation20070—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—