510(k) Report

Devices descending from K971737

1,000 later devices reach Cynosure Photogenica Lpir Dermatological Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K193266MIINMedico USA, Inc.20210—
+6K202172StarWalkerFotona D.O.O.20203—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K192856MT OneM&T S.R.L.20202—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+6K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+6K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K181019Diode Laser SystemGuangzhou Huafei Tongda Technology Co., Ltd.20186—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+6K180593Vbeam Prima Laser SystemSyneron-Candela20182—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172791Lumilisse IPL Hair RemoverConair Corporation201825—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171702Exciplex308nmClarteis20175—
+6K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K163196ACTION II Laser SystemLutronic Corporation20170—
+6K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+6K163173Handheld Diode Laser for Hair RemovalLiaoning Sidey Optoelectronics Technologies Co., Ltd.20170—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K161669Waterlase ExpressBiolase, Inc.201621—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+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—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153229SuperbiumBios S.R.L.20162—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K160368EVO platformQuanta System Spa201636—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+6K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+6K152714Quanta ForteQuanta System Spa201513—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K143003iPulse Smooth Skin Gold Hair Removal SystemIpulse Limited2015123—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K143339Mini meIluminage Ltd.(Formerly Syneron Beauty Ltd.)20140—
+6K142093V20 SystemViora, Ltd.201432—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140120EPIC 10Biolase, Inc.20141—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K132518Nubrilliance Pulsed Light Hair Removal DeviceWellquest Intl., Inc.20140—
+6K140381Sensilight/ Sensilight PlusEl Global Trade, Ltd.201414—
+6K140527Sensilight MiniEl Global Trade, Ltd.201423—
+6K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+6K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+6K124064Young AgainEspansione Marketing S.P.A20131—
+6K130459Tria Fan SystemTria Beauty, Inc.20131—
+6K124043Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp.20130—
+6K131870Glide DeviceHome Skinovations, Ltd.201333—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+6K122200A3F FrationalPollogen, Ltd.20130—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K121327Diolase 10SBiolase Technology, Inc.20132—
+6K123845MESyneron Beauty, Ltd.2013126—
+6K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+6K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+6K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+6K120080Shaser HRS2 Hair Removal SystemShaser, Inc.2012135—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+6K102461FractoraInvasix, Ltd.201124—
+6K103455Spectra Laser SystemLutronic Corporation201192—
+6K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+6K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+6K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+6K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+6K101321Ematrix CO2Syneron Medical, Ltd.20102—