510(k) Report

Devices descending from K990903

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+1K032397Dual Yellow Laser, Model Dual Yellow D10BNorseld Pty., Ltd.20042—
+1K033251The Friendlylight ND: Yag LasersInnotech USA, Inc.2004519—
+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—
+1K022464Equilase SystemEquilasers, Inc.20020—
+1K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739—
+1K994116Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America20000—
+1K994260Candela Gentlelase GL Dermatological LaserCandela Corp.2000258—
+2K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+2K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+2K213350mJOULE System and AccessoriesSciton, Inc20220—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+2K193656SkyPulseFotona D.O.O.202011—
+2K161503ORIONYerim Engineering Co., Ltd.20161—
+2K132976AdvatxAdvalight Aps20141—
+2K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+2K111144Candela Gentlelase Family of LasersCandela Corp.201191—
+2K101916Joule Multi-Platform SystemSciton, Inc2011111—
+2K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+2K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+2K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+2K083207Ultrawave Iii EX 1320Quanta System Spa2008961
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K062369Iridex Oculight TXIridex Corp200673—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K051876Multiwave XRPacific Quantum Instruments, Inc.20050—
+2K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd.2004517—
+2K042474ARIONWavelight Laser Technologie AG2004114—
+2K041829Focus Medical Naturalase LP and Naturalight Family of ProductsFocus Medical, LLC20044—
+2K041262Duralite-GLLaser Scientific20040—
+2K040384Mydon CWavelight Laser Technologie AG200451—
+2K030508Depilase Trio Lase Laser SystemDepilase Group, Ltd.20030—
+2K024371Candela Gentle Lase Family of Laser SystemCandela Corp.2003207—
+2K024260Candela Gentlelase Family of Laser SystemsCandela Corp.20031861
+2K022923Candela Gentle Yag Laser SystemCandela Corp.2003656—
+2K024335Candela Gentlelase Family of Laser SystemsCandela Corp.20031871
+2K023193Candela Gentle Yag Laser SystemCandela Corp.2002656—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc.2002665—
+2K020412Depilase Twin Lase Laser SystemDepilase Group, Ltd.2002106—
+3K250189AdvaTxAdvalight Aps20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K180224Element-TLElemenic Co., Ltd.20180—
+3K173285Joule SystemSciton, Inc20185—
+3K170850Alma QAlma Lasers, Ltd.20172—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+3K143666Noblex Long Pulse Alexandrite LaserFinemec Co., Ltd.20150—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K140249Long Pulse ND: Yag Laser SystemAdvanced Technology Laser Co., Ltd.20143—
+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—
+3K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+3K130256MDK Multi-Applications PlatformQuanta System Spa201338—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K123168Q-Plus T+ Ipl Laser SystemQuanta System Spa2012401
+3K112715Candela Gentlemax Family of LasersCandela Corp.201190—
+3K110370Q-ClearLight Age, Inc.201135—
+3K103626Cutera Genesisplus Laser SystemCutera, Inc.2011121—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K091534Lightlas Model 532Lightmed Corp.200972—
+3K090762LEDAQuantel Derma GmbH200946—
+3K090571Alma Lasers ALEX755 ModuleAlma Lasers, Ltd.200958—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+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—
+3K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd.2008266—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K072344Apl Medical SystemBios S.R.L.20076—
+3K063427Lumina Intense Pulsed Light (& Laser) SystemLynton Lasers Limited20070—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K063571Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc.2007160—
+3K063074Candela 3630 Laser SystemCandela Corp.2006179—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K051359Candela Family of Pulsed Dye Laser Systems: Pigmented Lesion Handpiece AccessoryCandela Corp.200511
+3K050293Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of…Fotona D.D.2005200—
+3K050218Wavelight SinonWavelight Laser Technologie AG20050—
+3K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp.2005136—
+3K032991Light Age Epicare Alexandrite Laser, Models 501-1H, 501-SP, 501-LP and 501-LPXLight Age, Inc.200461—
+3K033072Lucentlite, Model Imd 010Industrial & Medical Design, Inc.20040—
+3K033172Candela Gentleyag Family of Laser SystemsCandela Corp.2003654—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—