510(k) Report

Devices descending from K003715

763 later devices reach Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+4K232236EchoQuanta System Spa20230—
+4K230660AviClear Laser SystemCutera, Inc.20231—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213261EpilMENeauvia North America20220—
+4K213594Echolaser X4Elesta S.P.A20221—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K202172StarWalkerFotona D.O.O.20203—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K192856MT OneM&T S.R.L.20202—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+4K171227StarWalkerFotona D.O.O.20177—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K153229SuperbiumBios S.R.L.20162—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152012EVO platformQuanta System Spa201537—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150907Ellipse Nordlys/Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity, Ellipse Mjolner…Ellipse A/S20155—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K140122Candela Gentlemax Family of Laser SystemCandela Corp.201410—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+4K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+4K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+4K091534Lightlas Model 532Lightmed Corp.200972—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+4K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+4K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+4K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+4K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+4K073111Portrait PSR, Model 745915Rhytec Incorporated20084—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K072344Apl Medical SystemBios S.R.L.20076—
+4K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—