510(k) Report

Devices descending from K040005

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K221268SR-1 Skin Treatment SystemAVAVA, Inc.20223—
+6K213674CellFX SystemPulse Biosciences, Inc.20220—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K222075CellFX SystemPulse Biosciences, Inc.20220—
+6K221671CellFX® SystemPulse Biosciences, Inc.20220—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.20220—
+6K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering20221—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K211639BTL-785WBTL Industries, Inc.20227—
+6K212107ReversoIntelis Instruments, Ltd.20211—
+6K203441The Alma Hybrid Laser SystemAlma Lasers, Ltd.20215—
+6K203788DermaV Laser SystemLutronic Corporation202101
+6K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+6K193266MIINMedico USA, Inc.20210—
+6K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+6K202172StarWalkerFotona D.O.O.20203—
+6K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+6K201406PicowonWontech Co., Ltd.20200—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K200736Stardust MedI.T.S. Group S.R.L.20200—
+6K200786Venus EpileveVenus Concept USA, Inc.20200—
+6K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+6K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+6K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+6K192545PotenzaJeisys Medical Incorporated202020—
+6K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+6K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K183156V-LaserWontech Co., Ltd.20193—
+6K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K181518Sebacia MicroparticlesSebacia, Inc.20180—
+6K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20182—
+6K173503Pollogen Legend SystemPollogen, Ltd.20183—
+6K180406Ellipse YdunEllipse A/S20180—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K172096FraxisIlooda Co,., Ltd.20172—
+6K170325Secret RFIlooda Co,., Ltd.201710—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+6K161185LUCERNA Dental LaserViax Dental Lab20160—
+6K161455Catalys Precision Laser SystemOptimedica Corporation20167—
+6K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+6K153566Magma SystemFormatk Systems, Ltd.20162—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K152611V20 systemViora, Ltd.20164—
+6K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+6K150035V10 systemViora, Ltd.201531—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K131839DC 7Dc International, LLC20130—
+6K130465EPIC 10SBiolase Technology, Inc.20130—
+6K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+6K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+6K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+7K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+7K252723Dynamis Pro FamilyFotona D.O.O.20260—
+7K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+7K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+7K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+7K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+7K253342PICO-KSpeclipse, Inc.20251—
+7K251730LIA Console (542-7)Leadoptik, Inc.20250—
+7K253344Bellus-QSpeclipse, Inc.20250—
+7K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+7K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—
+7K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+7K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+7K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K251230The Alma Hybrid Laser SystemAlma Lasers, Inc.20250—
+7K251094Alma VeilWontech Co., Ltd.20250—
+7K250809Stellar M22Lumenis Be, Ltd.20250—
+7K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+7K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+7K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa20240—
+7K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+7K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+7K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+7K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+7K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+7K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—