510(k) Report

Devices descending from K041710

353 later devices reach Versawave Dental ER:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K251094Alma VeilWontech Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K241600DermablateAsclepion Laser Technologies GmbH20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+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—
+5K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+5K190936Q-Switched Nd: YAG Laser SystemShanghai Apolo Medical Technology Co., Ltd.20194—
+5K180508Joule SystemSciton, Inc20183—
+5K173692D-Actor 200 Vibration Massage SystemStorz Medical AG20186—
+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—
+5K163222Discovery Pico FamilyQuanta System Spa201630—
+5K161670Lucid Q-PTP / HWA 55Bison Medical Co, Ltd.20164—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K140837Lucid LYBio-Med USA, Inc.20140—
+5K131757Tattoostar Effect ComboAsclepion Laser Technologies GmbH20140—
+5K133774AtovenBio-Med USA, Inc.20146—
+5K133254Revlite Q-Switched ND:Yag Laser SystemCynosure, Inc.201457—
+5K130250Qyag Laser SystemPalomar Medical Technologies, Inc.20130—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K122922E-Beam ND: Yag LaserEclipse Aesthetics, LLC20137—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+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—
+6K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.20260—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K261964Echolaser X4Elesta S.P.A20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.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—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K243488Vmat ProTermosalud20250—
+6K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+6K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+6K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+6K233344Regenalase Laser SystemIpg Medical20240—
+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—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—
+6K223680Eneka ProTermosalud20230—
+6K210166Omnispec ED1000Medispec, Ltd.20230—
+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—
+6K222369PURE LaserEndymed Medical, Ltd.20220—
+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—
+6K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+6K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K212082PicoreBio-Med USA, Inc.20210—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+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—
+6K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+6K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+6K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+6K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+6K173700PICOPLUS Laser SystemLutronic Corporation20187—
+6K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+6K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+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—
+6K152856Helios IIILaseroptek Co., Ltd.20165—
+6K160480PicoSure WorkstationCynosure, Inc.201620—
+6K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+6K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—