510(k) Report

Devices descending from K003765

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc.2010282
+4K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc.2010156—
+4K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K090025Matrix RF ApplicatorSyneron Medical, Ltd.201018—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083900Erbium Fractional HandpiecePalomar Medical Products, Inc.2009158—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K080496Mosaic ECO2 Laser SystemLutronic Corporation200830—
+4K080915Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc.2008187—
+4K081219Apollo Mini Ipl SystemSandstone Medical Technologies, LLC20083—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—
+4K080374Biosyag Medical SystemBios S.R.L.20082—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K070392Mosaic Laser SystemLutronic Corporation20078—
+4K071152Palomar Erbium HandpiecePalomar Medical Products, Inc.2007159—
+4K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc.2007172—
+4K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2007259—
+4K062303Fraxel II SR Laser SystemReliant Technologies, Inc.2007226—
+4K060977Medlite C Series Compression Tool and Handpiece Attachment Accessory, Model 659-0523Hoya Conbio, Inc.20060—
+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—
+5K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+5K260153Q-Switched Nd: YAG Laser System (Glamor Q)Nanjing Bestview Laser S&T Co., Ltd.20260—
+5K260632Laser Thermal Therapy KitElesta S.P.A20260—
+5K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K250936Q-Switched Nd:YAG Laser (SHE-LSP101-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+5K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+5K250722Nd: YAG Laser Therapy System (QN-1)Hebei JT Medical Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243630Medical Laser System Incanto / Evoline Platinum /EvolineSolar LS Cjsc20250—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K231910DermRays ReviveWuhan Lotuxs Technology Co., Ltd.20240—
+5K232236EchoQuanta System Spa20230—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K231054V-LaserWontech Co., Ltd.20231—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K223680Eneka ProTermosalud20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K223540AvalancheLase FamilyFotona D.O.O.20230—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+5K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+5K222369PURE LaserEndymed Medical, Ltd.20220—
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221571InMode Multi-systemInMode, Ltd.20222—
+5K213261EpilMENeauvia North America20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K213594Echolaser X4Elesta S.P.A20221—
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K201520The Alma Opus System, Colibri Applicator and TipsAlma Lasers, Inc.20211—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K203788DermaV Laser SystemLutronic Corporation202101
+5K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+5K203299CellFX SystemPulse Biosciences, Inc.20214—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K201064V30 System, V20 System, V10 System, V-FR HandpieceViora, Ltd.20200—
+5K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+5K191554LightWalker Laser System FamilyFotona D.O.O.201919—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K183566CLARITY II Laser SystemLutronic Corporation201911
+5K183156V-LaserWontech Co., Ltd.20193—
+5K180359BTL-FR2000BTL Industries, Inc.20189—
+5K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+5K182663Nobleen Long Pulsed Alexandrite & Nd: YAG Laser SystemFinemec Co., Ltd.20180—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—