510(k) Report

Devices descending from K991935

1,492 later devices reach Epilight Hair Removal System, Photoderm HR System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180406Ellipse YdunEllipse A/S20180—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171052Ultimate Contour, Ultimate Contour MiniCAO Group, Inc.20171—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K170068Softcure 96Wellray Medical Laser, Inc.20170—
+6K163415SlimShape SystemSyneron Medical, Ltd.201714—
+6K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017106—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K162489RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd.201755—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K162512truSculptCutera, Inc.20165—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K160329InMode System MiniFX HandpieceInmode MD, Ltd.20167—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K152087HeatLux Pro IIHome Skinovations, Ltd.20160—
+6K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.20160—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc.20160—
+6K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K160227ACCENTO / HWA Dual/Single laserBison Medical Co, Ltd.20160—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K153718Spirit Hair Removal laser FamilyActive Optical Systems, Ltd.20167—
+6K152898Diode Laser Therapy SystemsBeijing Sincoheren Science and Tech. Development Co., Ltd.20161—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+6K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+6K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+6K150724SculpSureCynosure, Inc.201521—
+6K143559XP1000 RFBTL Industries, Inc.20157—
+6K150230SculpSureCynosure, Inc.201521—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K143109XP300BTL Industries, Inc.20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142924Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System FamilyShaser, Inc.20150—
+6K141986Elux 810 LaserEquipmed North America, Inc.20150—
+6K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+6K140732Candela Gentlelase Family of Laser SystemsCandela Corp.20141—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K131838Diode Laser for Hiar RemovalBeijing Honkon Technologies Co., Ltd.20140—
+6K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd.20142—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K130689Symphony RF GeneratorThermigen, Inc.201311—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K132665Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc.201317—
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K123483Diode LaserBeijing Syntech Laser CO., LTD.201353—
+6K123889Acleara, TheraclearTheravant Corporation20130—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K111501I-Lipo SystemChromogenex Technologies Limited201215—
+6K110375Blueshine's Gold SeriesBlueshine Srl20124—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+6K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+6K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+6K082938EzlaseBiolase Technology, Inc.200850—
+6K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd.20260—
+7K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—