510(k) Report

Devices descending from K971207

781 later devices reach Softlight Q-Switched (ND:Yag) Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192620SNA-001 Silver Photoparticle Topical GelSienna Biopharmaceuticals, Inc.20200—
+1K150212DeScribe Transparent PFD PatchOn Light Sciences, Inc.20153—
+1K022709Medlite Q-Swithced LaserContinuum Electro-Optics, Inc.2003742—
+1K023967Palomar Q-Yag ND:Yag Laser SystemPalomar Medical Technologies, Inc.2003554—
+2K190542Soliton Acoustic Wave DeviceSoliton, Inc.20191—
+2K172689DESCRIBE PFD PatchMerz North America, Inc.20170—
+2K061850Mini-Yag LaserAmerican Lasers, Inc.20060—
+2K053139Fotona QX ND:Yag/KTP Laser SystemFotona D.D.2006168—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K033946Lovely SystemMsq (M2), Ltd.2004737—
+2K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+2K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc.200476—
+3K200331Rapid Acoustic Pulse DeviceSoliton, Inc.20200—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K110370Q-ClearLight Age, Inc.201135—
+3K083203Helios II Q-Switched ND:Yag Laser SystemLaseroptek Co., Ltd.20096—
+3K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+3K081408Ellipse MultiflexEllipse A/S20087—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063249BeamaxMedic Sharplight, Ltd.200758—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K053324Chromolite SystemChromogenex Plc200631—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K042630Revlight Skin Care SystemSkincare Technology, Inc.2005402—
+3K043173Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd.200539—
+3K041969Aurora DSSyneron Medical, Ltd.2004302—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K202172StarWalkerFotona D.O.O.20203—
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K171227StarWalkerFotona D.O.O.20177—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K152856Helios IIILaseroptek Co., Ltd.20165—
+4K153229SuperbiumBios S.R.L.20162—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152012EVO platformQuanta System Spa201537—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142860Lumenis M22 SystemLumenis, Ltd.2015381
+4K140670Ellipse I2PL+/Ellipse Multiflex+Ellipse A/S201461
+4K131142Genesis Led WandsGenesis Biosystems, Inc.20130—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K102461FractoraInvasix, Ltd.201124—
+4K103455Spectra Laser SystemLutronic Corporation201192—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K093465Fusion SystemEclipsemed Global, Inc.20100—
+4K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+4K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+4K082484Accelawave SystemGenesis Biosystems, Inc.200829—
+4K081578Accela SystemGenesis Biosystems, Inc.20080—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K060792IllumimedPhotoactif, LLC2006115—
+4K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+4K050796Aurora DS, DS ApplicatorSyneron Medical, Ltd.2005301—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K253765Vanish ProDdc Technologies, Inc.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K253342PICO-KSpeclipse, Inc.20251—
+5K253344Bellus-QSpeclipse, Inc.20250—
+5K250165PastelleWontech Co., Ltd.20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K241527Pastelle ProWontech Co., Ltd.20253—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K231948MediyagMedicreations, LLC20240—