510(k) Report

Devices descending from K972325

318 later devices reach Pulsemaster 1000 ST Dental Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+5K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+5K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K180508Joule SystemSciton, Inc20183—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K163128Epic ProBiolase, Inc.201716—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K132661LightscalpelLightscalpel, LLC20143—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+5K123494SOLEAConvergent Dental, Inc.201331
+5K123004Mira LasersMira Lasers, LLC20130—
+5K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+5K102639SL3Discus Dental, LLC201011
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+5K060033Profile Multi-Platform SystemSciton, Inc2006221—
+6K260138LUNE PureHygieneEnamel Pure20260—
+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—
+6K244060eCO2 3DLutronic Corporation20250—
+6K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K210847UltraClear Fractional Laser SystemFa International, LP20210—
+6K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K172771Epic Pro 940Biolase, Inc.20171—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K141658Light ScalpelLightscalpel, LLC20142—
+6K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+6K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+6K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+7K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+7K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+7K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+7K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+7K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+7K230308Alma HarmonyAlma Lasers, Inc.20232—
+7K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+7K223680Eneka ProTermosalud20230—
+7K222915Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE…Canadian Pioneer Medical Technology Corporation (Cpmt Laser)20220—
+7K222064The Alma Soprano TitaniumAlma Lasers, Inc.202214—
+7K222369PURE LaserEndymed Medical, Ltd.20220—
+7K221761SoleaConvergent Dental, Inc.202201
+7K214049Leaseir MHR XcellLeaseir Technologies, Slu202211
+7K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+7K211722Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation20221—
+7K203728DarwinLuvo Medical Technologies, Inc.20211—
+7K202258ERISE Laser handpieceEl.En Electronic Engineering Spa20210—
+7K201594Primelase ExcellenceHigh Technology Products S.L.U20202—
+7K200118Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20201—
+7K192483MeDioStarAsclepion Laser Technologies GmbH20203—
+7K192269TwinScan 808/755 Laser SystemGme German Medical Engineering GmbH20190—
+7K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+7K182045Lotus III Multi-Pulsed Er: Yag Laser SystemLaseroptek Co., Ltd.20180—
+7K182088XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP SpectroFotona D.O.O.201820—
+7K173827LightScalpelLightscalpel, LLC20180—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K180719InMode Diolaze SystemInmode MD, Ltd.201813—
+7K181298Harmony XL Multi-Application PlatformAlma Lasers, Inc.20183—
+7K171227StarWalkerFotona D.O.O.20177—
+7K153671Family of CoolGlide Aesthetic LasersCutera, Inc.201632—
+7K152714Quanta ForteQuanta System Spa201513—
+7K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K101573Accusculpt II Laser SystemLutronic Corporation20101—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+7K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+8K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+8K253251Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece…Leaseir Technologies, Slu20260—
+8K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—
+8K252561BTL-754FFBTL Industries, Inc.20260—
+8K242859VEGAIbramed Equipamentos Médicos20250—