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
+7K211639BTL-785WBTL Industries, Inc.20227—
+7K213428EdgeProBiolase, Inc.20210—
+7K212107ReversoIntelis Instruments, Ltd.20211—
+7K211821DEKA Motus AZEl.En Electronic Engineering Spa20211—
+7K193266MIINMedico USA, Inc.20210—
+7K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+7K201406PicowonWontech Co., Ltd.20200—
+7K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+7K200736Stardust MedI.T.S. Group S.R.L.20200—
+7K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+7K192545PotenzaJeisys Medical Incorporated202020—
+7K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+7K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173503Pollogen Legend SystemPollogen, Ltd.20183—
+7K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+7K180406Ellipse YdunEllipse A/S20180—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171648BM.IrisBluecore Co., Ltd.20172—
+7K172096FraxisIlooda Co,., Ltd.20172—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K170325Secret RFIlooda Co,., Ltd.201710—
+7K162755PicocareWontech Co., Ltd.20179—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+7K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+7K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+7K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+7K152611V20 systemViora, Ltd.20164—
+7K150664NeoLasSheaumann Laser, Inc.20151—
+7K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+7K150035V10 systemViora, Ltd.201531—
+7K150326PicoWay Laser SystemCandela Corporation201568—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+7K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+7K142372Pico Way Laser SystemCandela Corpation201470—
+7K140837Lucid LYBio-Med USA, Inc.20140—
+7K140719Picosure WorkstationCynosure, Inc.201450—
+7K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+7K131837CO2 Fractional LaserBeijing Honkon Technologies Co., Ltd.20140—
+7K130193Fraxel Dual 1550/1927 Laser SystemSolta Medical, Inc.201325—
+7K123573Youlaser CO2 LaserQuanta System Spa201319—
+7K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+7K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+7K110333Naturalase CO2 Laser SystemFocus Medical, LLC20121—
+7K120433Clear + Brilliant Laser SystemSolta Medical, Inc.20121—
+7K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc.2009158—
+7K091115ECO2 Laser SystemLutronic Corporation200927—
+7K090639EXELO2, Model 4010Quantel Derma GmbH20090—
+7K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc.2009158—
+7K090525Loi SystemPalomar Medical Products, Inc.20099—
+7K080932Mosaic Laser SystemLutronic Corporation20086—
+7K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+7K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+8K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+8K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+8K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+8K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+8K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+8K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+8K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+8K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+8K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+8K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+8K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+8K243488Vmat ProTermosalud20250—
+8K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K242349FoLixLumenis Be, Ltd.20240—
+8K241459MOTUS PRO FamilyEl.En S.P.A.20240—
+8K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+8K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+8K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+8K233550MOSAIC 3D (Surgical Laser)Lutronic Aesthetic20240—
+8K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+8K222556BTL-785XBTL Industries, Inc.20235—
+8K221865BTL-094BTL Industries, Inc.20230—
+8K210166Omnispec ED1000Medispec, Ltd.20230—
+8K223647CLEAR+BRILLIANT TOUCH® Laser SystemSolta Medical, Inc.20220—
+8K221574LUDWIG Electrosurgical DeviceAesthetics Biomedical20220—
+8K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+8K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+8K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+8K211979Lumenis Y&R Laser SystemLumenis, Inc.20220—
+8K212663Helios IV 785Laseroptek Co., Ltd.20223—
+8K213332Multifrax Laser SystemParadigm Medical Corporation20220—
+8K210084SilkroHironic Co., Ltd.20223—
+8K220124YandR System, VoluDerm Handpiece, VoluDerm TipsPollogen, Ltd.20220—
+8K212492Frax 1940 for Nordlys and Frax ProCandela Corporation20210—