510(k) Report

Devices descending from K000990

304 later devices reach Opus 10 Dental Diode Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050453Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc.200586—
+1K031819Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd.20030—
+1K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+2K160413Sterling 5W Diode LaserCAO Group, Inc.20160—
+2K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+2K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+2K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+2K083142Picasso Laser SystemAmd Lasers, LLC200916—
+2K083034Fotona XD-2 Diode Laser System, Model MD01-2FFotona D.D.200913—
+2K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+2K062619Denlaser 800 PlusCAO Group, Inc.200640—
+2K062074Iridex Wireless FootswitchIridex Corp20060—
+2K062071Prometey, Model G1-03Spectrum International200617—
+2K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K193656SkyPulseFotona D.O.O.202011—
+3K161185LUCERNA Dental LaserViax Dental Lab20160—
+3K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC201512—
+3K142223Pilot Pro Diode LaserCAO Group, Inc.20140—
+3K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+3K132661LightscalpelLightscalpel, LLC20143—
+3K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+3K123494SOLEAConvergent Dental, Inc.201331
+3K123004Mira LasersMira Lasers, LLC20130—
+3K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+3K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+3K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+3K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+3K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+3K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+3K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+3K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+3K071896Fox 940, Model 940Valam, Inc.20080—
+3K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+3K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+3K060033Profile Multi-Platform SystemSciton, Inc2006221—
+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—
+4K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+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—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+4K193486Epic 980Biolase, Inc.20202—
+4K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+4K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+4K151306SoleaConvergent Dental, Inc.20151—
+4K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K141658Light ScalpelLightscalpel, LLC20142—
+4K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+4K131839DC 7Dc International, LLC20130—
+4K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+4K130420SOLEAConvergent Dental, Inc.201321
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+4K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+4K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH201126—
+4K102639SL3Discus Dental, LLC201011
+4K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+4K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+4K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+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—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K234085LUNE™ PureHygieneEnamel Pure20241—
+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
+5K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+5K214008Dental diode laserShenzhen Soga Technology Co., Ltd.20220—
+5K200693K2 MobileHulaser, Inc.20202—
+5K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+5K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+5K173827LightScalpelLightscalpel, LLC20180—
+5K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+5K180044SIROLaser BlueDentsply Sirona201812—
+5K173285Joule SystemSciton, Inc20185—
+5K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+5K170500SIROLaser Advance+Dentsply Sirona201721—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+5K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—