510(k) Report

Devices descending from K011041

373 later devices reach Waterlase, Millennium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052354Oculase MDBiolase Technology, Inc.20065—
+1K030523WaterlaseBiolase Technology, Inc.20048—
+1K030539LasersmileBiolase Technology, Inc.2003327—
+1K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+2K141975Waterlase Iplus SBiolase, Inc.20150—
+2K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+2K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+2K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+2K083142Picasso Laser SystemAmd Lasers, LLC200916—
+2K081652Claros Nano Dental Laser SystemElexxion AG20089—
+2K081589Waterlase, Version 3.0Biolase Technology, Inc.20081—
+2K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+2K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+2K063152Claros Dental Laser SystemElexxion AG200753—
+2K061898EzlaseBiolase Technology, Inc.2007289—
+2K062071Prometey, Model G1-03Spectrum International200617—
+2K050453Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc.200586—
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+3K193486Epic 980Biolase, Inc.20202—
+3K160413Sterling 5W Diode LaserCAO Group, Inc.20160—
+3K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC201512—
+3K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+3K132661LightscalpelLightscalpel, LLC20143—
+3K123494SOLEAConvergent Dental, Inc.201331
+3K123004Mira LasersMira Lasers, LLC20130—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+3K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+3K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+3K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+3K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+3K083034Fotona XD-2 Diode Laser System, Model MD01-2FFotona D.D.200913—
+3K083069Ezlase 10WBiolase Technology, Inc.200836—
+3K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+3K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+3K072262Gentleray 980 Diode Laser SystemKavo America200751—
+3K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+3K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+3K062619Denlaser 800 PlusCAO Group, Inc.200640—
+3K062074Iridex Wireless FootswitchIridex Corp20060—
+3K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K244060eCO2 3DLutronic Corporation20250—
+4K234085LUNE™ PureHygieneEnamel Pure20241—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+4K210183Waterlase iPLusBiolase, Inc.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+4K200693K2 MobileHulaser, Inc.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+4K192430Epic 980Biolase, Inc.20195—
+4K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+4K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K161185LUCERNA Dental LaserViax Dental Lab20160—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K141658Light ScalpelLightscalpel, LLC20142—
+4K142223Pilot Pro Diode LaserCAO Group, Inc.20140—
+4K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+4K131839DC 7Dc International, LLC20130—
+4K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+4K113489ORIONAsclepion Laser Technologies GmbH20120—
+4K110375Blueshine's Gold SeriesBlueshine Srl20124—
+4K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K102639SL3Discus Dental, LLC201011
+4K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+4K094049Stlase Diode LaserDental Photonics, Inc.201023—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K100558Quanta Diode Laser SystemQuanta System Spa201068—
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+4K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+4K090762LEDAQuantel Derma GmbH200946—
+4K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K073411LiteduoLight Instruments20081—
+4K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+4K071896Fox 940, Model 940Valam, Inc.20080—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+4K070388Profile Multi-Platform SystemSciton, Inc2007129—
+4K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K261964Echolaser X4Elesta S.P.A20260—
+5K260138LUNE PureHygieneEnamel Pure20260—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—