510(k) Report

Devices descending from K010834

728 later devices reach Lyra Series Surgical Laser System & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+1K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+1K013047Fotona Dualis ND:Yag Laser System, Fotona Twinlight ND:Yag Laser SystemMojca Valijavec20010—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+2K213350mJOULE System and AccessoriesSciton, Inc20220—
+2K113115Epicare YagLight Age, Inc.20120—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+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—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+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—
+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—
+2K040384Mydon CWavelight Laser Technologie AG200451—
+3K233024Alma HarmonyAlma Lasers, Inc.20241—
+3K230308Alma HarmonyAlma Lasers, Inc.20232—
+3K220214Painless IPL System - KDT750Shanghai Omni Laser Skinology Co., Ltd.20230—
+3K213761Joule diVa SystemSciton, 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—
+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—
+3K173285Joule SystemSciton, Inc20185—
+3K171227StarWalkerFotona D.O.O.20177—
+3K170850Alma QAlma Lasers, Ltd.20172—
+3K161926ND YAG Q-switch Laser Therapy MachineBeijing Adss Development Co., Ltd.20175—
+3K153229SuperbiumBios S.R.L.20162—
+3K152012EVO platformQuanta System Spa201537—
+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
+3K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+3K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+3K132976AdvatxAdvalight Aps20141—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+3K130459Tria Fan SystemTria Beauty, Inc.20131—
+3K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+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—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+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—
+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—
+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—
+3K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+3K091534Lightlas Model 532Lightmed Corp.200972—
+3K090762LEDAQuantel Derma GmbH200946—
+3K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+3K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+3K073572Matrix RF ApplicatorSyneron Medical, Ltd.2008102—
+3K082028Laserpeel Soft-Met Modified Erbium LaserGlobal USA Distribution, LLC20080—
+3K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+3K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+3K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+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—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+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—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K063038Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc.2007195—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc.2006230—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc.2005284—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—