510(k) Report

Devices descending from K933582

250 later devices reach Profile Series 29 Files through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K092933Saf (Self Adjusting File)Redent-Nova, Ltd.20100—
+1K962031Quantec Series 2000 Endodontic FilesTycom Dental1996249—
+2K012511Waterlase MillenniumBiolase Technology, Inc.2002246—
+2K971319NT Series Endodontic Files, Mac Series Endodontic FilesTycom Dental19970—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K030523WaterlaseBiolase Technology, Inc.20048—
+3K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+4K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+4K081589Waterlase, Version 3.0Biolase Technology, Inc.20081—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+5K132661LightscalpelLightscalpel, LLC20143—
+5K123494SOLEAConvergent Dental, Inc.201331
+5K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+5K060033Profile Multi-Platform SystemSciton, Inc2006221—
+6K244060eCO2 3DLutronic Corporation20250—
+6K213761Joule diVa SystemSciton, Inc20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+6K151306SoleaConvergent Dental, Inc.20151—
+6K141658Light ScalpelLightscalpel, LLC20142—
+6K130420SOLEAConvergent Dental, Inc.201321
+6K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+6K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+6K101916Joule Multi-Platform SystemSciton, Inc2011111—
+6K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+6K073411LiteduoLight Instruments20081—
+6K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+6K070388Profile Multi-Platform SystemSciton, Inc2007129—
+6K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+7K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+7K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+7K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+7K221761SoleaConvergent Dental, Inc.202201
+7K193656SkyPulseFotona D.O.O.202011—
+7K173827LightScalpelLightscalpel, LLC20180—
+7K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+7K173285Joule SystemSciton, Inc20185—
+7K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+7K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+7K132976AdvatxAdvalight Aps20141—
+7K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+7K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+7K101573Accusculpt II Laser SystemLutronic Corporation20101—
+7K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+7K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+7K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+7K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+7K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+7K081352Profile Multi-Platform SystemSciton, Inc2008112—
+7K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+7K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+7K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+8K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+8K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+8K250189AdvaTxAdvalight Aps20250—
+8K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+8K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+8K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+8K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+8K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+8K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+8K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+8K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+8K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+8K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+8K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+8K193367elysion-proHigh Technology Products S.L.U20203—
+8K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+8K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+8K180508Joule SystemSciton, Inc20183—
+8K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+8K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+8K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+8K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+8K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+8K141237Harmony LiteAlma, Inc.20154—
+8K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+8K133774AtovenBio-Med USA, Inc.20146—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+8K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+8K100558Quanta Diode Laser SystemQuanta System Spa201068—
+8K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+8K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+9K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+9K261964Echolaser X4Elesta S.P.A20260—
+9K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+9K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+9K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+9K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+9K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—