510(k) Report

Devices descending from K954316

382 later devices reach Aurora Surgical Diode Laser System W/Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+1K042211Modification to: Laserpro 810, 940, and 980 Diode Diode Laser SystemsSurgical Laser Technologies, Inc.2004303—
+1K040294Laserpro Diode Laser Systems, Models 810, 940 & 980Photo Medex, Inc.2004306—
+1K991994TwilightBiolase Technology, Inc.1999280—
+1K983058Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc.1998208—
+1K974586Aurora Diode Laser SystemPremier Laser Systems, Inc.1998318—
+1K972325Pulsemaster 1000 ST Dental Laser SystemAmerican Dental Technologies, Inc.1997318—
+2K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+2K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+2K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+2K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+2K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+2K083069Ezlase 10WBiolase Technology, Inc.200836—
+2K071896Fox 940, Model 940Valam, Inc.20080—
+2K072779Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.2008153—
+2K071815Noveon, Model LS1100-01-0968Nomir Medical Technologies, Inc.20070—
+2K072262Gentleray 980 Diode Laser SystemKavo America200751—
+2K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+2K063384Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc.200713—
+2K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA2006299—
+2K053161SirolaserSirona Dental Systems GmbH200679—
+2K031819Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd.20030—
+2K012511Waterlase MillenniumBiolase Technology, Inc.2002246—
+2K991891Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc.1999207—
+3K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+3K193656SkyPulseFotona D.O.O.202011—
+3K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+3K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+3K163638Dental 5 Multi Diode laserBio-Med USA, Inc.20170—
+3K140120EPIC 10Biolase, Inc.20141—
+3K121286EPIC 10Biolase Technology, Inc.201231—
+3K113489ORIONAsclepion Laser Technologies GmbH20120—
+3K110375Blueshine's Gold SeriesBlueshine Srl20124—
+3K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH201126—
+3K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K094049Stlase Diode LaserDental Photonics, Inc.201023—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+3K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+3K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+3K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+3K090762LEDAQuantel Derma GmbH200946—
+3K091323Modified Intermedic Diode Laser 980NM System (Multidiode SST 200)Intermedic Arfran, SA20090—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+3K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+3K073411LiteduoLight Instruments20081—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007229—
+3K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007230—
+3K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.200722—
+3K052354Oculase MDBiolase Technology, Inc.20065—
+3K030523WaterlaseBiolase Technology, Inc.20048—
+3K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+4K261964Echolaser X4Elesta S.P.A20260—
+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—
+4K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+4K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+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—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+4K222701MANTA LaserSqualus Med, Ltd.20222—
+4K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+4K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+4K214008Dental diode laserShenzhen Soga Technology Co., Ltd.20220—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K200693K2 MobileHulaser, Inc.20202—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K193486Epic 980Biolase, Inc.20202—
+4K192430Epic 980Biolase, Inc.20195—
+4K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K173285Joule SystemSciton, Inc20185—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K161185LUCERNA Dental LaserViax Dental Lab20160—
+4K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+4K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K151629Guardian 1000Quanta System Spa20150—
+4K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K141975Waterlase Iplus SBiolase, Inc.20150—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+4K131839DC 7Dc International, LLC20130—
+4K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—