510(k) Report

Devices descending from K040005

572 later devices reach Profile 2000/3000 Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+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—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+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—
+5K202288FinebeamSNJ Co., Ltd.20212—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K193201BTL-785FBtl20208—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193426Elite iQCynosure, LLC20201—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20181—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.20180—
+5K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+5K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20183—
+5K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20171—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20171—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering201521
+5K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20152—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20153—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K140120EPIC 10Biolase, Inc.20141—
+5K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation201483
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+5K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K232236EchoQuanta System Spa20230—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—