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
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc.2008159—
+5K063808Fraxel IV SR Laser SystemReliant Technologies, Inc.200734—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K253828Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)Beijing HuaCheng Taike Technology Co., Ltd.20260—
+6K251836Dermatrix DuoShenzhen Gsd Technology Co., Ltd.20260—
+6K252877SANDRO DualWontech Co., Ltd.20250—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+6K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+6K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+6K251031Fiber Laser Treatment Systems (HS-232,HS-233)Shanghai Apolo Medical Technology Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K250809Stellar M22Lumenis Be, Ltd.20250—
+6K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+6K243488Vmat ProTermosalud20250—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)Bios S.R.L.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K233473Deka LotusEl.En S.P.A.20241—
+6K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+6K233143PiXel8-RevealRohrer Aesthetics20240—
+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—
+6K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)Candela Corporation20230—
+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—
+6K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+6K221761SoleaConvergent Dental, Inc.202201
+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—
+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—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K191065Venus VivaTMVenus Concept USA, Inc.20200—
+6K192951Ellipse Frax 1940 for Ellipse Nordlys and Ellipse YdunEllipse A/S20201—
+6K193426Elite iQCynosure, LLC20201—
+6K192331LaseMD LEO Laser SystemLutronic Global20190—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K182173Joule SystemSciton, Inc20195—
+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—
+6K180406Ellipse YdunEllipse A/S20180—
+6K180224Element-TLElemenic Co., Ltd.20180—
+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—