510(k) Report

Devices descending from K040081

415 later devices reach Palomar Luxv Handpiece through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K200468V30 system, V20 system, V10 system, V-FC HandpieceViora, Ltd.20200—
+5K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K183156V-LaserWontech Co., Ltd.20193—
+5K181868SHINY RPL SystemIds, Ltd.20181—
+5K181518Sebacia MicroparticlesSebacia, Inc.20180—
+5K180406Ellipse YdunEllipse A/S20180—
+5K173677InMode VLazeInmode MD, Ltd.20183—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K171648BM.IrisBluecore Co., Ltd.20172—
+5K171711Thunder, Thunder VT, Thunder HRQuanta System Spa20170—
+5K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K152611V20 systemViora, Ltd.20164—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K151655CO2RE SystemSyneron Medical, Ltd.20151—
+5K150035V10 systemViora, Ltd.201531—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140727Cutera Picosecond Laser SystemCutera, Inc.201447—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K133945Cutera Picosecond Laser SystemCutera, Inc.201414—
+5K133364Picosure WorkstationCynosure, Inc.201451—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K131095Deka Synchro Repla: Y Family of Laser SystemsEl.En Electronic Engineering Spa201317—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K121346Picosure WorkstationCynosure, Inc.201287—
+5K090094Zeltiq SystemZeltiq Aesthetics200932—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K243223Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)Bh Group Us, LLC20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+6K251094Alma VeilWontech Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K223871Miria Skin Treatment SystemAVAVA, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+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—
+6K213120OW100S (model OW100S-US)Tissue Regeneration Technologies, LLC Dba AS Softwave Trt20220—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K221427V-LaserWontech Co., Ltd.20222—
+6K221789IRIS Pi Q switched Nd YAG laserBio-Med USA, Inc.20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K193266MIINMedico USA, Inc.20210—
+6K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+6K202758Nd: YAG Laser Therapy Systems HM-YL900Shangdong Huamei Technology Co., Ltd.20202—
+6K201406PicowonWontech Co., Ltd.20200—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+6K181523Syneron CO2RE SystemSyneron-Candela Corp20180—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+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—
+6K170637sensiFirmEl Global Trade, Ltd.20173—
+6K162755PicocareWontech Co., Ltd.20179—
+6K170597PicoWay Laser SystemSyneron Candela Corporation201732—
+6K162454PicoWay Laser SystemSyneron Candela Corporation201733—
+6K160488Cutera enlighten III Laser SystemCutera, Inc.201613—
+6K161043Profound SystemSyneron Candela Corporation20160—
+6K161199EndyMed Contour HandpieceEndymed Medical, Ltd.20162—
+6K153568InMode Plus SystemInmode MD, Ltd.201618—
+6K160607PicoWay Laser SystemSyneron Candela Corporation201634—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K153527PicoWay Laser SystemSyneron Candela Corporation201641—
+6K150326PicoWay Laser SystemCandela Corporation201568—
+6K150516Deka Synchro Repla:Y Family of Laser SystemsEl.En Electronic Engineering Spa201516—
+6K143105Picosure WorkstationCynosure, Inc.201549—
+6K142372Pico Way Laser SystemCandela Corpation201470—
+6K140719Picosure WorkstationCynosure, Inc.201450—
+6K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.201231—
+7K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+7K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+7K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+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—
+7K242859VEGAIbramed Equipamentos Médicos20250—
+7K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+7K251632Optimas MAX SystemInMode, Ltd.20251—
+7K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+7K240983Discovery Pico; Discovery Pico Plus; Discovery Pico DermQuanta System Spa20251—
+7K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+7K250402AVAVA™ Skin Treatment SystemAVAVA, Inc.20251—