510(k) Report

Devices descending from K010284

357 later devices reach Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+1K032218Adept 1064/532/755 LaserAdept Medical Concepts2003104—
+1K032221Adept 1064/755 LaserAdept Medical Concepts20030—
+1K032220Adept 1064/532 LaserAdept Medical Concepts2003126—
+1K023881Profile 1064 Laser SystemSciton, Inc2003227—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+2K213350mJOULE System and AccessoriesSciton, Inc20220—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+2K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+2K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K062369Iridex Oculight TXIridex Corp200673—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K040384Mydon CWavelight Laser Technologie AG200451—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K193656SkyPulseFotona D.O.O.202011—
+3K173285Joule SystemSciton, Inc20185—
+3K170850Alma QAlma Lasers, Ltd.20172—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+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—
+3K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+3K091534Lightlas Model 532Lightmed Corp.200972—
+3K090762LEDAQuantel Derma GmbH200946—
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K082938EzlaseBiolase Technology, Inc.200850—
+3K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+4K250189AdvaTxAdvalight Aps20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K233024Alma HarmonyAlma Lasers, Inc.20241—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K181510Echolaser X4El.En Electronic Engineering Spa20183—
+4K180508Joule SystemSciton, Inc20183—
+4K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+4K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152012EVO platformQuanta System Spa201537—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K141237Harmony LiteAlma, Inc.20154—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+4K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+5K260632Laser Thermal Therapy KitElesta S.P.A20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—