510(k) Report

Devices descending from K040131

569 later devices reach Cooltouch; Cooltouch II; and Cooltouch CT3 ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K233473Deka LotusEl.En S.P.A.20241—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.20240—
+5K221865BTL-094BTL Industries, Inc.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K210166Omnispec ED1000Medispec, Ltd.20230—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+5K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K212607DarwinLuvo Medical Technologies, Inc.20210—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K212082PicoreBio-Med USA, Inc.20210—
+5K211444CellFX SystemPulse Biosciences, Inc.20213—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K202988Tixel SystemNovoxel, Ltd.20211—
+5K193266MIINMedico USA, Inc.20210—
+5K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+5K193201BTL-785FBtl20208—
+5K201164Venus Viva MD DeviceVenus Concept USA, Inc.20203—
+5K191065Venus VivaTMVenus Concept USA, Inc.20200—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191942MT One DiamondM&T S.R.L.20191—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+5K173700PICOPLUS Laser SystemLutronic Corporation20187—
+5K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd.201838—
+5K173199PicoSure WorkstationCynosure, Inc.20189—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+5K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+5K171359Pollogen Legend+ SystemPollogen, Ltd.20174—
+5K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+5K162363V30 system, V-Form Handpiece BC Medium applicatorViora, Ltd.20163—
+5K160312Fraxis DuoIlooda Co,., Ltd.201614—
+5K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+5K152856Helios IIILaseroptek Co., Ltd.20165—
+5K160480PicoSure WorkstationCynosure, Inc.201620—
+5K153717Venus Versa SystemVenus Concept, Ltd.20161—
+5K151273InMode FRF ApplicatorInmode MD, Ltd.20163—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K143105Picosure WorkstationCynosure, Inc.201549—
+5K142093V20 SystemViora, Ltd.201432—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K142376Palomar Icon Aesthetic SystemCynosure, Inc.201413—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K130028Resurfx 1565NM Laser ModuleLumenis, Ltd.201341—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K113868Eplus Skin Treatment SystemSyneron, Ltd.20120—
+5K120622Palomar Vectus LaserPalomar Medical Technologies, Inc.20124—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111840Emerge Fractional LaserPalomar Medical Products, Inc.20113—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+5K100558Quanta Diode Laser SystemQuanta System Spa201068—
+5K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K253123CuRAS hybridClassys, Inc.20250—
+6K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+6K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+6K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250281Deka LotusEl.En S.P.A.20250—
+6K241270BTL-754BTL Industries, Inc.20251—
+6K243139Reverso Pro SystemIndiba S. A. U.20250—
+6K233118DUET-V (Model: ESK-3261DV)Eunsung Global Corp20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240017InMode System with the Morpheus8 90 ApplicatorInMode, Ltd.20240—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K232192Venus Versa PRO SystemVenus Concept, Inc.20230—
+6K230077LaserMENeauvia North America20232—
+6K223033Tixel® 2 SystemNovoxel, Ltd.20230—
+6K223680Eneka ProTermosalud20230—
+6K222701MANTA LaserSqualus Med, Ltd.20222—
+6K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+6K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—