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
+3K091625Epicare-Duo Laser SystemLight Age, Inc.20091—
+3K091534Lightlas Model 532Lightmed Corp.200972—
+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—
+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—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K253765Vanish ProDdc Technologies, Inc.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+4K250189AdvaTxAdvalight Aps20250—
+4K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+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—
+4K240752Deka ToroEl.En S.P.A.20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K234057NirvanaEl.En S.P.A.20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+4K232236EchoQuanta System Spa20230—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K231054V-LaserWontech Co., Ltd.20231—
+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—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K223540AvalancheLase FamilyFotona D.O.O.20230—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K22079410PLTentech Co., Ltd.20220—
+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—
+4K212790XLase PlusBiotec Italia, Srl20220—
+4K221571InMode Multi-systemInMode, Ltd.20222—
+4K213261EpilMENeauvia North America20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K203788DermaV Laser SystemLutronic Corporation202101
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200616E>EyeCE-Swin20200—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K183156V-LaserWontech Co., Ltd.20193—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181518Sebacia MicroparticlesSebacia, Inc.20180—
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+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—
+4K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+4K171702Exciplex308nmClarteis20175—
+4K172413MT ONEM&T S.R.L.20175—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—