510(k) Report

Devices descending from K041957

297 later devices reach Evlt Kit and the D15PLUS and D30PLUS Diode Lasers through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+1K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+1K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc.2006132—
+1K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.200589—
+2K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+2K110375Blueshine's Gold SeriesBlueshine Srl20124—
+2K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+2K100558Quanta Diode Laser SystemQuanta System Spa201068—
+2K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+2K090762LEDAQuantel Derma GmbH200946—
+2K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+2K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+2K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+2K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+2K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+2K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+3K261964Echolaser X4Elesta S.P.A20260—
+3K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+3K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K222701MANTA LaserSqualus Med, Ltd.20222—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K200104OxylightRaja Trading Company, Inc.202024—
+3K181510Echolaser X4El.En Electronic Engineering Spa20183—
+3K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+3K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+3K151629Guardian 1000Quanta System Spa20150—
+3K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+3K140120EPIC 10Biolase, Inc.20141—
+3K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+3K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+3K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+3K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+3K121327Diolase 10SBiolase Technology, Inc.20132—
+3K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+3K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+3K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+3K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K092734E-Light LineEspansione Marketing S.P.A20102—
+3K094049Stlase Diode LaserDental Photonics, Inc.201023—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K260632Laser Thermal Therapy KitElesta S.P.A20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+4K233344Regenalase Laser SystemIpg Medical20240—
+4K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+4K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+4K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+4K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+4K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+4K213594Echolaser X4Elesta S.P.A20221—
+4K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+4K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+4K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K173285Joule SystemSciton, Inc20185—