510(k) Report

Devices descending from K021548

253 later devices reach Fotona Dualis ND:Yag/ER:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K223566ELITA™ Femtosecond Laser System, ELITA™ Patient InterfaceJohnson & Johnson Surgical Vision, Inc.20230—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221427V-LaserWontech Co., Ltd.20222—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K182795LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20181—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+5K173371VisuMax Femtosecond LaserCarl Zeiss Meditec, Inc.20180—
+5K173660LenSx Laser SystemAlcon Laboratories, Inc.20182—
+5K173346LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20183—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K171014VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20171—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K170576LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20171—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K150323FEMTO LDV Z8 Surgical LaserSie Ag,Surgical Instrument Engineering201521
+5K152453LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20152—
+5K141379Victus Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20153—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K141079Optimedica Catalys Precision Laser SystemOptimedica Corporation201483
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K243896LenSx Laser System (8065998162)Alcon Laboratories, Inc.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243488Vmat ProTermosalud20250—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K221865BTL-094BTL Industries, Inc.20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+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—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K220259ALLY Adaptive Cataract Treatment SystemLensar, Inc.20220—
+6K213559FEMTO LDV Z8 Femtosecond Surgical LaserSie Ag,Surgical Instrument Engineering20221—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+6K193266MIINMedico USA, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K200724VICTUS Femtosecond Laser PlatformTechnolas Perfect Vision GmbH20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K181430LENSAR Laser System - fs 3D (LLS-fs 3D)Lensar, Inc.20182—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K173199PicoSure WorkstationCynosure, Inc.20189—
+6K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+6K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+6K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161455Catalys Precision Laser SystemOptimedica Corporation20167—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+7K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+7K253123CuRAS hybridClassys, Inc.20250—
+7K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+7K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+7K252682LenSx Laser System (8065000944)Alcon Laboratories, Inc.20250—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+7K241656Eneka SelectifTermosalud20241—
+7K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+7K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+7K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+7K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—
+7K212663Helios IV 785Laseroptek Co., Ltd.20223—
+7K202848S2 Pigment Removal SystemLightsense Technologies, Ltd.20210—
+7K210226PicoSure WorkstationCynosure, LLC20213—
+7K193477Nd: YAG Laser Therapy SystemsBeijing Kes Biology Technology Co., Ltd.20202—
+7K200116PicoSecond Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20206—
+7K182997enlighten III Laser SystemCutera, Inc.20180—
+7K172376Discovery Pico, Discovery Pico PlusQuanta System Spa201720—
+7K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+7K170322Catalys Precision Laser SystemAbbott Medical Optics, Inc.201761
+7K170936Cutera enlighten III Laser SystemCutera, Inc.201710—