510(k) Report

Devices descending from K010104

741 later devices reach Candela Long Pulse ND:Yag through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+1K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+1K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+1K022951Candela Gentle Yag Laser System, Variable Pulse YagCandela Corp.2003657—
+1K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+2K161503ORIONYerim Engineering Co., Ltd.20161—
+2K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+2K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+2K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+2K113115Epicare YagLight Age, Inc.20120—
+2K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+2K083889Fotona QX ND:Yag/KTP Laser System FamilyFotona D.D.2009166—
+2K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+2K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+2K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+2K063074Candela 3630 Laser SystemCandela Corp.2006179—
+2K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+2K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+2K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+2K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+2K023881Profile 1064 Laser SystemSciton, Inc2003227—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213350mJOULE System and AccessoriesSciton, Inc20220—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K192856MT OneM&T S.R.L.20202—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K180224Element-TLElemenic Co., Ltd.20180—
+3K171227StarWalkerFotona D.O.O.20177—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K152012EVO platformQuanta System Spa201537—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+3K110370Q-ClearLight Age, Inc.201135—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—
+3K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+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—
+3K081324Candela Family of Q-Switched Alexandrite LasersCandela Corp.2008112—
+3K073534Candela Family of Q-Switched Alexandrite Laser (Alexlazr) SystemsCandela Corp.2008113—
+3K070355Fotona Fidelis Iii ER:Yag/ND:Yag Laser System FamilyFotona D.D.2008194—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K071051Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007194—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K062369Iridex Oculight TXIridex Corp200673—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+3K040384Mydon CWavelight Laser Technologie AG200451—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K252561BTL-754FFBTL Industries, 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—
+4K231948MediyagMedicreations, LLC20240—
+4K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—