510(k) Report

Devices descending from K980537

1,242 later devices reach ND: Yag Accessory for Photoderm System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K180406Ellipse YdunEllipse A/S20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K171323Biophotas CELLUMA3Biophotas, Inc.201756—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+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—
+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—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163—
+6K152737Lite TouchFocus Medical, LLC20160—
+6K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation20160—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151629Guardian 1000Quanta System Spa20150—
+6K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150—
+6K150554NuBrilliance Light Pain TherapyWellquest International, Inc.20150—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154—
+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—
+6K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC201555—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+6K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+6K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+6K130199Clarity LPC Laser SystemLutronic Corporation20135—
+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—
+6K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+6K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K123573Youlaser CO2 LaserQuanta System Spa201319—
+6K123889Acleara, TheraclearTheravant Corporation20130—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K121286EPIC 10Biolase Technology, Inc.201231—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+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—
+6K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+6K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+6K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+6K102461FractoraInvasix, Ltd.201124—
+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—
+6K091115ECO2 Laser SystemLutronic Corporation200927—
+6K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+6K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+6K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+6K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+6K082197Rhytec, Inc., Portrait PSRRhytec Incorporated20083—
+6K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics200833—
+6K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+6K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+6K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+6K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+6K050673Candela Family of Pulse Dye Laser SystemsCandela Corp.20051332
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—