510(k) Report

Devices descending from K022839

251 later devices reach Fotona Dualis Plus ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K221761SoleaConvergent Dental, Inc.202201
+5K221427V-LaserWontech Co., Ltd.20222—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K213428EdgeProBiolase, Inc.20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K200971308nm Excimer SystemXuzhou Kernel Medical Equipment Co., Ltd.20201—
+5K202827308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.20200—
+5K192642308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20202—
+5K191086ExciplexClarteis20194—
+5K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K162556Lightfusion Led SystemVitage Led, Ltd.20170—
+5K160368EVO platformQuanta System Spa201636—
+5K150664NeoLasSheaumann Laser, Inc.20151—
+5K112669Tattoostar Effect YAsclepion Laser Technologies GmbH20128—
+5K113588Spectra Laser SystemLutronic Corporation201282—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+6K260511Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20260—
+6K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K253054LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.20250—
+6K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K251464TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)Jeisys Medical Incorporated20250—
+6K251727GLAM LED Facial Mask (TB-2386F)Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.20250—
+6K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.20252—
+6K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd.20250—
+6K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251—
+6K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K242977308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…Xuzhou Kernel Medical Equipment Co., Ltd.20250—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+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—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+6K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+6K173677InMode VLazeInmode MD, Ltd.20183—
+6K171648BM.IrisBluecore Co., Ltd.20172—
+6K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+6K163222Discovery Pico FamilyQuanta System Spa201630—
+6K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+6K140837Lucid LYBio-Med USA, Inc.20140—
+6K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+6K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+6K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+6K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+7K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd.20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K243488Vmat ProTermosalud20250—
+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—
+7K221865BTL-094BTL Industries, Inc.20230—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+7K210166Omnispec ED1000Medispec, Ltd.20230—
+7K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+7K220538DolorClast RadialE.M.S Electro Medical Systems S.A20221—
+7K221571InMode Multi-systemInMode, Ltd.20222—
+7K212082PicoreBio-Med USA, Inc.20210—
+7K210451OrthoGold 100Tissue Regeneration Technologies, LLC20212—
+7K193266MIINMedico USA, Inc.20210—
+7K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+7K173700PICOPLUS Laser SystemLutronic Corporation20187—
+7K173199PicoSure WorkstationCynosure, Inc.20189—
+7K173038CuRAS Nd:YAG LaserIlooda Co,., Ltd.20176—
+7K172077Cutera enlighten III Laser SystemCutera, Inc.20179—
+7K171945Discovery Pico, Discovery Pico PlusQuanta System Spa201721—
+7K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+7K152856Helios IIILaseroptek Co., Ltd.20165—
+7K160480PicoSure WorkstationCynosure, Inc.201620—
+7K143105Picosure WorkstationCynosure, Inc.201549—
+8K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K260375Nd: YAG Laser Therapy SystemsSanhe Meditech Co., Ltd.20260—
+8K253123CuRAS hybridClassys, Inc.20250—
+8K252515Q-Switched Nd:Yag laser (K690)Hebei Keylaser Sci-Tech Co.,Ltd20250—
+8K252319Q-Switched Nd: YAG Laser machine (LFS-C13U)Sanhe Lefis Electronics Co., Ltd.20250—
+8K251632Optimas MAX SystemInMode, Ltd.20251—
+8K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+8K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+8K242206ActivoDaeju Meditech Engineering Co., Ltd.20240—
+8K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+8K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+8K222555reepot Nd; YAG laser systemIlooda Co,., Ltd.20220—