510(k) Report

Devices descending from K962354

300 later devices reach Diomed 15, 30, 60 Surgical Diode Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013499Diomed 15 Plus and Diomed 30PLUS LasersDiomed, Inc.2001298—
+1K980142Featherlite Diode LaserLaserlite, LLC19980—
+2K051996Diomed Delta 15, Model Delta 15; Diomed Delta 30, Model Delta 30Diomed, Ltd.200589—
+2K041957Evlt Kit and the D15PLUS and D30PLUS Diode LasersDiomed, Inc.20042971
+3K243701AuroLase® SystemNanospectra Biosciences, Inc.20250—
+3K181044400um Perforator and Accessory Vein Ablation KitAngioDynamics, Inc.20180—
+3K093502Vari-Lase Endovenous Laser ConsoleVascular Solutions, Inc.20100—
+3K090126Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model…Fotona D.D.200980—
+3K080959Dornier Medilas D 30 Laser, Medilas D 1064Dornier Medtech America, Inc.20084—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K063828Diomed Delta 25Diomed, Ltd.20075—
+3K062822Vari-Lase Endovenous Laser Console, Model 7500Vascular Solutions, Inc.2006132—
+4K202288FinebeamSNJ Co., Ltd.20212—
+4K181510Echolaser X4El.En Electronic Engineering Spa20183—
+4K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+4K132286Hyperion Long Pulsed ND: Yag LaserScarlet Rf, Inc.20143—
+4K121508Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-NFotona D.D.20121—
+4K120235Model Family of Aerolase ND:Yag Lasers: Friendlylight ND: Yag Lasers, Friendlylight Neo…Aerolase Medical Lasers, LLC201233—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K101306SP Dynamis, SP Spectro, XS Dynamis, XS Spectro, XP Dynamis, XP Spectro, Models…Fotona D.D.201178—
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K090762LEDAQuantel Derma GmbH200946—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K080104Vari-Lase Endovenous Laser Console, Model 7542Vascular Solutions, Inc.20080—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+5K260632Laser Thermal Therapy KitElesta S.P.A20260—
+5K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+5K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+5K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K222701MANTA LaserSqualus Med, Ltd.20222—
+5K213594Echolaser X4Elesta S.P.A20221—
+5K200104OxylightRaja Trading Company, Inc.202024—
+5K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc.20190—
+5K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+5K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+5K171227StarWalkerFotona D.O.O.20177—
+5K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+5K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+5K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+5K151629Guardian 1000Quanta System Spa20150—
+5K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+5K150140MCL 31 DermablateAsclepion Laser Technologies GmbH20157—
+5K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+5K140120EPIC 10Biolase, Inc.20141—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K094049Stlase Diode LaserDental Photonics, Inc.201023—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+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—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K213761Joule diVa SystemSciton, Inc20220—