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
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd.20246—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241656Eneka SelectifTermosalud20241—
+6K241293LED Light Therapy Device, ELIXIR MD™Yassen Wellness, LLC20247—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233224Epilaser ProEpilady 2000, LLC20240—
+6K233077FlashHeal 2 (FlashHeal 2.0)Inwound Aps20240—
+6K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K222790F65 Laser SystemLumenis Be, Ltd.20233—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+6K222221Deka HelixEl.En Electronic Engineering Spa20231—
+6K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K221761SoleaConvergent Dental, Inc.202201
+6K221427V-LaserWontech Co., Ltd.20222—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+6K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+6K213428EdgeProBiolase, Inc.20210—
+6K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K211444CellFX SystemPulse Biosciences, Inc.20213—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K202988Tixel SystemNovoxel, Ltd.20211—
+6K193266MIINMedico USA, Inc.20210—
+6K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+6K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K193201BTL-785FBtl20208—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K201111GentleMax Pro PlusCandela Corporation20203—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K200110SANDRO DualWontech Co., Ltd.20202—
+6K193426Elite iQCynosure, LLC20201—
+6K191086ExciplexClarteis20194—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K182173Joule SystemSciton, Inc20195—
+6K183452Vbeam Prima Laser SystemCandela Corp.20191—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K182669Youlaser CO2Quanta System Spa20181—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K181486DEKA Motus AYEl.En Electronic Engineering Spa20182—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K163137NIRA Beauty Skin LaserDermal Photonics Corporation20171—
+6K171009LASEMD Laser SystemLutronic Corporation20178—
+6K162886Deka Motus AXEl.En Electronic Engineering Spa20171—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L.20161—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K160312Fraxis DuoIlooda Co,., Ltd.201614—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153717Venus Versa SystemVenus Concept, Ltd.20161—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K152529NaturaLase CO2 Laser SystemFocus Medical, LLC20160—
+6K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+6K150664NeoLasSheaumann Laser, Inc.20151—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150027CYMAWhitecap Technologies, LLC20150—
+6K143105Picosure WorkstationCynosure, Inc.201549—