510(k) Report

Devices descending from K020021

740 later devices reach Lyra Surgical Laser System and Accessiories (ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+1K063828Diomed Delta 25Diomed, Ltd.20075—
+1K040384Mydon CWavelight Laser Technologie AG200451—
+1K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+1K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+1K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+1K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+1K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+1K031828Naturalase LP ND:Yag LaserFocus Medical, LLC20035—
+1K023881Profile 1064 Laser SystemSciton, Inc2003227—
+1K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+1K030510Depilase Twin Yag Laser SystemDepilase Group, Ltd.20030—
+1K030506Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd.20030—
+1K022951Candela Gentle Yag Laser System, Variable Pulse YagCandela Corp.2003657—
+1K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+2K213350mJOULE System and AccessoriesSciton, Inc20220—
+2K181510Echolaser X4El.En Electronic Engineering Spa20183—
+2K170850Alma QAlma Lasers, Ltd.20172—
+2K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+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—
+2K110370Q-ClearLight Age, Inc.201135—
+2K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K090762LEDAQuantel Derma GmbH200946—
+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—
+2K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+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—
+2K062369Iridex Oculight TXIridex Corp200673—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+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—
+2K050218Wavelight SinonWavelight Laser Technologie AG20050—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+2K040617Reliant Laser System IIReliant Technologies, Inc.2004316—
+2K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K260632Laser Thermal Therapy KitElesta S.P.A20260—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K232117Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)Wuhan Lotuxs Technology Co., Ltd.20231—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K213594Echolaser X4Elesta S.P.A20221—
+3K213569HOLLYWOOD SPECTRA Laser SystemLutronic Corporation20227—
+3K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K202172StarWalkerFotona D.O.O.20203—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K192856MT OneM&T S.R.L.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+3K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+3K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+3K173677InMode VLazeInmode MD, Ltd.20183—
+3K173285Joule SystemSciton, Inc20185—
+3K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd.201714—
+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—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K142860Lumenis M22 SystemLumenis, Ltd.2015381
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K141555AdvantageLutronic Corporation201414—
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+3K122493GenesisplusCutera, Inc.201318—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+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—
+3K113843Freedom ND: Yag Laser SystemLutronic Corporation20120—
+3K113702Fotona XP ND: Yag Laser SystemFotona D.D.201265—
+3K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+3K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+3K111483Joule Clearsense Laser SystemSciton, Inc20110—
+3K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K103455Spectra Laser SystemLutronic Corporation201192—
+3K103288Deka Synchro FTEl.En Electronic Engineering Spa201118—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K093162Fidelis Plus Iii D, at Fidelis D, Powerlase at D / Fidelis Plus Iii, at Fidelis…Fotona D.D.201083—
+3K093465Fusion SystemEclipsemed Global, Inc.20100—