510(k) Report

Devices descending from K042000

517 later devices reach Modified MSQ Family of Lovely Light/Laser Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K223680Eneka ProTermosalud20230—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+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—
+5K213674CellFX SystemPulse Biosciences, Inc.20220—
+5K222075CellFX SystemPulse Biosciences, Inc.20220—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K221671CellFX® SystemPulse Biosciences, Inc.20220—
+5K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+5K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+5K211639BTL-785WBTL Industries, Inc.20227—
+5K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+5K212107ReversoIntelis Instruments, Ltd.20211—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202884SR-1 Skin Treatment SystemAVAVA, Inc.20214—
+5K193266MIINMedico USA, Inc.20210—
+5K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+5K202247V30 system, V20 system, V10 system, V-VR Hand pieceViora, Ltd.20200—
+5K201406PicowonWontech Co., Ltd.20200—
+5K200736Stardust MedI.T.S. Group S.R.L.20200—
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+5K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+5K193426Elite iQCynosure, LLC20201—
+5K192545PotenzaJeisys Medical Incorporated202020—
+5K192695InMode System with the Morpheus8 (Fractora) ApplicatorsInmode MD, Ltd.201916—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+5K173503Pollogen Legend SystemPollogen, Ltd.20183—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171227StarWalkerFotona D.O.O.20177—
+5K170060M22 and ResurFx SystemsLumenis, Ltd.201724—
+5K172096FraxisIlooda Co,., Ltd.20172—
+5K170325Secret RFIlooda Co,., Ltd.201710—
+5K162755PicocareWontech Co., Ltd.20179—
+5K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+5K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+5K162765Venus Velocity Diode Laser SystemVenus Concept, Ltd.20171—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K161162Frax 1550 for Ellipse Nordlys/ Ellipse Nordlys+, Ellipse Sirius, Ellipse Infinity…Ellipse A/S20164—
+5K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+5K152611V20 systemViora, Ltd.20164—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K150035V10 systemViora, Ltd.201531—
+5K150326PicoWay Laser SystemCandela Corporation201568—
+5K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142860Lumenis M22 SystemLumenis, Ltd.2015381
+5K142372Pico Way Laser SystemCandela Corpation201470—
+5K140120EPIC 10Biolase, Inc.20141—
+5K140719Picosure WorkstationCynosure, Inc.201450—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+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—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+6K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+6K251988Boston iFace (Boston iFace)Boston Aesthetics, Inc.20260—
+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—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250782Fractional CO2 Laser MachineZhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+6K241832Unicorn+ RF System (Unicorn+); Unicorn+ RF System (Unicorn+ I); Unicorn+ RF System…Boston Aesthetics, Inc.20251—
+6K242183Fractional CO2 Laser Therapy System (EXFU CO2)Weifang Mingliang Electronics Co., Ltd.20240—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K241600DermablateAsclepion Laser Technologies GmbH20240—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+6K222958mJOULE RF System and AccessoriesSciton, Inc20240—
+6K233757TitanPico Laser Workstation (PICO-450)Rhein Laser Technologies Co., Ltd.20240—
+6K240396Elite iQ PRO (M122K1)Cynosure, LLC20240—
+6K233090DEKA AGAIN PRO familyEl.En S.P.A.20232—
+6K232236EchoQuanta System Spa20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K222556BTL-785XBTL Industries, Inc.20235—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—