510(k) Report

Devices descending from K083613

192 later devices reach Quanta System Polysurge Diode Laser Family through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+1K101916Joule Multi-Platform SystemSciton, Inc2011111—
+1K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+1K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+1K100558Quanta Diode Laser SystemQuanta System Spa201068—
+1K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+2K261964Echolaser X4Elesta S.P.A20260—
+2K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+2K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+2K222701MANTA LaserSqualus Med, Ltd.20222—
+2K213761Joule diVa SystemSciton, Inc20220—
+2K193656SkyPulseFotona D.O.O.202011—
+2K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+2K173285Joule SystemSciton, Inc20185—
+2K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+2K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+2K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+2K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+2K140120EPIC 10Biolase, Inc.20141—
+2K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+2K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+2K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+2K132976AdvatxAdvalight Aps20141—
+2K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+2K121327Diolase 10SBiolase Technology, Inc.20132—
+2K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+2K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+2K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+3K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+3K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+3K250189AdvaTxAdvalight Aps20250—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+3K233344Regenalase Laser SystemIpg Medical20240—
+3K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+3K210183Waterlase iPLusBiolase, Inc.20220—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+3K193367elysion-proHigh Technology Products S.L.U20203—
+3K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+3K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+3K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+3K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+3K180508Joule SystemSciton, Inc20183—
+3K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+3K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+3K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+3K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+3K161185LUCERNA Dental LaserViax Dental Lab20160—
+3K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+3K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+3K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K141237Harmony LiteAlma, Inc.20154—
+3K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+3K131839DC 7Dc International, LLC20130—
+3K130465EPIC 10SBiolase Technology, Inc.20130—
+3K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+3K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+3K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+3K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+3K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+4K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+4K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+4K251730LIA Console (542-7)Leadoptik, Inc.20250—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+4K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+4K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K230308Alma HarmonyAlma Lasers, Inc.20232—
+4K223680Eneka ProTermosalud20230—
+4K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+4K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+4K222369PURE LaserEndymed Medical, Ltd.20220—
+4K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+4K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+4K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+4K210847UltraClear Fractional Laser SystemFa International, LP20210—
+4K203728DarwinLuvo Medical Technologies, Inc.20211—
+4K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+4K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+4K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+4K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+4K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—