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
+4K252561BTL-754FFBTL Industries, Inc.20260—
+4K253342PICO-KSpeclipse, Inc.20251—
+4K253344Bellus-QSpeclipse, Inc.20250—
+4K250165PastelleWontech Co., Ltd.20250—
+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—
+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—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+4K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+4K232716Q-Switched Nd:Yag laserHebei Zhemai Technology 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—
+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—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+4K200616E>EyeCE-Swin20200—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K193464ND:YAG LaserBeijing Superlaser Technology Co., Ltd.20201—
+4K193367elysion-proHigh Technology Products S.L.U20203—
+4K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+4K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+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—
+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—
+4K172819LightWalker Laser System FamilyFotona D.O.O.201720—
+4K172413MT ONEM&T S.R.L.20175—
+4K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+4K163196ACTION II Laser SystemLutronic Corporation20170—
+4K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+4K153566Magma SystemFormatk Systems, Ltd.20162—
+4K160368EVO platformQuanta System Spa201636—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K152714Quanta ForteQuanta System Spa201513—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K141868Tria FanpTria Beauty, Inc.20140—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K133837Viora V-TotalViora, Ltd.201433—
+4K133319ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd.201424—
+4K133283Candela Gentlemax Family of Laser SystemsCandela Corp.201313—
+4K132185Family of Coolglide Aesthetic LasersCutera, Inc.201336—
+4K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+4K130199Clarity LPC Laser SystemLutronic Corporation20135—
+4K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+4K122200A3F FrationalPollogen, Ltd.20130—
+4K123293Pastelle Q-Switched ND: Yag LaserWon Technology Co., Ltd.20135—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K121150Alma Lasers Family of Pixel RF TipsAlma Lasers, Inc.20123—
+4K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+4K113588Spectra Laser SystemLutronic Corporation201282—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp.20112—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K102954Cutera Qswitch Laser SystemCutera, Inc.201149—
+4K102461FractoraInvasix, Ltd.201124—
+4K110304Apex ER. Yag / Ipl SystemSandstone Medical Technologies, LLC20112—
+4K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd.201164—
+4K101817Lightwalker at, Model M021-5AF/1, Lightwalker DT, Model M021-5AF/2, Lightwalker ST-E…Fotona D.D.20105—
+4K103118Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc.2010921
+4K101321Ematrix CO2Syneron Medical, Ltd.20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+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—
+4K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc.2008161—