510(k) Report

Devices descending from K922901

320 later devices reach Incisor I Pulsed ND:Yag Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974641Futurelase 3000/3002 Erbium Laser SystemBuckman Co., Inc.1998241—
+1K972325Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc.1997318—
+2K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+2K991994TwilightBiolase Technology, Inc.1999280—
+2K983058Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc.1998208—
+3K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K083069Ezlase 10WBiolase Technology, Inc.200836—
+3K072779Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.2008153—
+3K072262Gentleray 980 Diode Laser SystemKavo America200751—
+3K063384Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc.200713—
+3K053161SirolaserSirona Dental Systems GmbH200679—
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K031819Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd.20030—
+3K012511Waterlase MillenniumBiolase Technology, Inc.2002246—
+3K991891Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc.1999207—
+4K193656SkyPulseFotona D.O.O.202011—
+4K163638Dental 5 Multi Diode laserBio-Med USA, Inc.20170—
+4K140120EPIC 10Biolase, Inc.20141—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K121286EPIC 10Biolase Technology, Inc.201231—
+4K113489ORIONAsclepion Laser Technologies GmbH20120—
+4K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH201126—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+4K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+4K094049Stlase Diode LaserDental Photonics, Inc.201023—
+4K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+4K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+4K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+4K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+4K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+4K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+4K081352Profile Multi-Platform SystemSciton, Inc2008112—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+4K073411LiteduoLight Instruments20081—
+4K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+4K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+4K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K052354Oculase MDBiolase Technology, Inc.20065—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+4K030523WaterlaseBiolase Technology, Inc.20048—
+5K244060eCO2 3DLutronic Corporation20250—
+5K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+5K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+5K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+5K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+5K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+5K214008Dental diode laserShenzhen Soga Technology Co., Ltd.20220—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K200693K2 MobileHulaser, Inc.20202—
+5K193486Epic 980Biolase, Inc.20202—
+5K192430Epic 980Biolase, Inc.20195—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+5K180044SIROLaser BlueDentsply Sirona201812—
+5K173285Joule SystemSciton, Inc20185—
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K170500SIROLaser Advance+Dentsply Sirona201721—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K161185LUCERNA Dental LaserViax Dental Lab20160—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+5K141975Waterlase Iplus SBiolase, Inc.20150—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K131839DC 7Dc International, LLC20130—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+5K111689StlaseDental Photonics, Inc.201222—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+5K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+5K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+5K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K081589Waterlase, Version 3.0Biolase Technology, Inc.20081—
+5K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+5K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—