510(k) Report

Devices descending from K983100

248 later devices reach Kavo Key Laser 1242 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101658Waterlase MD Turbo Plus Model 7200XXXBiolase Technology, Inc.2010251
+1K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+2K190319Waterlase Laser System FamilyBiolase, Inc.201919—
+2K161669Waterlase ExpressBiolase, Inc.201621—
+2K120377Adverl Evo ER: Yag Laser for Dentistry Mey-1-aJ. Morita USA, Inc.20122—
+2K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K213428EdgeProBiolase, Inc.20210—
+3K193656SkyPulseFotona D.O.O.202011—
+3K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+3K150664NeoLasSheaumann Laser, Inc.20151—
+3K132661LightscalpelLightscalpel, LLC20143—
+3K123494SOLEAConvergent Dental, Inc.201331
+3K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+3K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+4K244060eCO2 3DLutronic Corporation20250—
+4K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+4K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+4K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+4K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K141658Light ScalpelLightscalpel, LLC20142—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K073411LiteduoLight Instruments20081—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+5K221761SoleaConvergent Dental, Inc.202201
+5K213267Dynamis Pro FamilyFotona D.O.O.20222—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K173827LightScalpelLightscalpel, LLC20180—
+5K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+5K173285Joule SystemSciton, Inc20185—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K101573Accusculpt II Laser SystemLutronic Corporation20101—
+5K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+5K081352Profile Multi-Platform SystemSciton, Inc2008112—
+5K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+5K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+6K252723Dynamis Pro FamilyFotona D.O.O.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+6K193367elysion-proHigh Technology Products S.L.U20203—
+6K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+6K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+6K180508Joule SystemSciton, Inc20183—
+6K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+6K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+6K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+6K141237Harmony LiteAlma, Inc.20154—
+6K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+6K133774AtovenBio-Med USA, Inc.20146—
+6K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+6K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+6K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+6K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+6K100558Quanta Diode Laser SystemQuanta System Spa201068—
+6K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871