510(k) Report

Devices descending from K023543

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc.2006132—
+1K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.200589—
+1K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc.20042971
+1K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc.2004303—
+1K040921Cooltouch, Model NS 160Cooltouch, Inc.2004204—
+1K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc.2004306—
+1K033237Vascular Solutions Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.2003133—
+1K030654Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.200311
+2K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+2K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+2K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+2K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+2K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+2K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+2K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+2K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+2K071896Fox 940, Model 940Valam, Inc.20080—
+2K073464Angiodynamics, Inc., Nevertouch II 400UM Fiber and Venacure Procedure KitAngioDynamics, Inc.20080—
+2K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070—
+2K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+2K070388Profile Multi-Platform SystemSciton, Inc2007129—
+2K063828Diomed Delta 25Diomed, Ltd.20075—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+2K032805Modification to Vascular Solutions Vari-Lase Endovenous Laser Procedure KitVascular Solutions, Inc.20030—
+3K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K202288FinebeamSNJ Co., Ltd.20212—
+3K181510Echolaser X4El.En Electronic Engineering Spa20183—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+3K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+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—
+3K110375Blueshine's Gold SeriesBlueshine Srl20124—
+3K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+3K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+3K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K101573Accusculpt II Laser SystemLutronic Corporation20101—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+3K090762LEDAQuantel Derma GmbH200946—
+3K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+3K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+3K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+3K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+3K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+4K260632Laser Thermal Therapy KitElesta S.P.A20260—
+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—
+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—
+4K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+4K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+4K222701MANTA LaserSqualus Med, Ltd.20222—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K213594Echolaser X4Elesta S.P.A20221—
+4K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K193656SkyPulseFotona D.O.O.202011—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+4K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+4K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K173285Joule SystemSciton, Inc20185—
+4K171227StarWalkerFotona D.O.O.20177—
+4K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+4K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+4K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+4K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K151629Guardian 1000Quanta System Spa20150—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K140120EPIC 10Biolase, Inc.20141—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K133774AtovenBio-Med USA, Inc.20146—
+4K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—