510(k) Report

Devices descending from K023967

554 later devices reach Palomar Q-Yag ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061850Mini-Yag LaserAmerican Lasers, Inc.20060—
+1K053139Fotona QX ND:Yag/KTP Laser SystemFotona D.D.2006168—
+1K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+1K033259Light Age Q-Clear Laser, Model 701-1101Light Age, Inc.200476—
+2K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+2K110370Q-ClearLight Age, Inc.201135—
+2K083203Helios II Q-Switched ND:Yag Laser SystemLaseroptek Co., Ltd.20096—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K043173Q-Switched ND:Yag Laser Treatment Head for the Lumenis Quantum SeriesLumenis, Ltd.200539—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K171227StarWalkerFotona D.O.O.20177—
+3K152856Helios IIILaseroptek Co., Ltd.20165—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K152012EVO platformQuanta System Spa201537—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+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—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K241527Pastelle ProWontech Co., Ltd.20253—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K231054V-LaserWontech Co., Ltd.20231—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K212663Helios IV 785Laseroptek Co., Ltd.20223—
+4K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K192856MT OneM&T S.R.L.20202—
+4K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+4K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+4K183156V-LaserWontech Co., Ltd.20193—
+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—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153229SuperbiumBios S.R.L.20162—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K160368EVO platformQuanta System Spa201636—
+4K141237Harmony LiteAlma, Inc.20154—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K133837Viora V-TotalViora, Ltd.201433—
+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—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+4K102461FractoraInvasix, Ltd.201124—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+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—
+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—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K252561BTL-754FFBTL Industries, Inc.20260—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K231948MediyagMedicreations, LLC20240—