510(k) Report

Devices descending from K030539

327 later devices reach Lasersmile through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+1K083142Picasso Laser SystemAmd Lasers, LLC200916—
+1K081652Claros Nano Dental Laser SystemElexxion AG20089—
+1K063152Claros Dental Laser SystemElexxion AG200753—
+1K061898EzlaseBiolase Technology, Inc.2007289—
+1K062071Prometey, Model G1-03Spectrum International200617—
+1K050453Odyssey 2.4G, Denlaser Elite, Model 002-00050Ivoclar Vivadent, Inc.200586—
+2K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+2K193486Epic 980Biolase, Inc.20202—
+2K160413Sterling 5W Diode LaserCAO Group, Inc.20160—
+2K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC201512—
+2K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+2K123004Mira LasersMira Lasers, LLC20130—
+2K121286EPIC 10Biolase Technology, Inc.201231—
+2K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+2K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+2K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+2K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+2K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+2K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+2K083034Fotona XD-2 Diode Laser System, Model MD01-2FFotona D.D.200913—
+2K083069Ezlase 10WBiolase Technology, Inc.200836—
+2K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+2K072262Gentleray 980 Diode Laser SystemKavo America200751—
+2K072034Diode Medical Laser Family, Models 4, 6, 30Quanta System Spa2007263—
+2K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+2K062619Denlaser 800 PlusCAO Group, Inc.200640—
+2K062074Iridex Wireless FootswitchIridex Corp20060—
+3K234085LUNE™ PureHygieneEnamel Pure20241—
+3K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+3K200693K2 MobileHulaser, Inc.20202—
+3K193656SkyPulseFotona D.O.O.202011—
+3K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+3K192430Epic 980Biolase, Inc.20195—
+3K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+3K170500SIROLaser Advance+Dentsply Sirona201721—
+3K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+3K161185LUCERNA Dental LaserViax Dental Lab20160—
+3K142223Pilot Pro Diode LaserCAO Group, Inc.20140—
+3K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+3K131839DC 7Dc International, LLC20130—
+3K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+3K113489ORIONAsclepion Laser Technologies GmbH20120—
+3K110375Blueshine's Gold SeriesBlueshine Srl20124—
+3K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+3K102639SL3Discus Dental, LLC201011
+3K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+3K094049Stlase Diode LaserDental Photonics, Inc.201023—
+3K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+3K100558Quanta Diode Laser SystemQuanta System Spa201068—
+3K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+3K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+3K090762LEDAQuantel Derma GmbH200946—
+3K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+3K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+3K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+3K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+3K071896Fox 940, Model 940Valam, Inc.20080—
+3K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+4K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K261964Echolaser X4Elesta S.P.A20260—
+4K260138LUNE PureHygieneEnamel Pure20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+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—
+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—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+4K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+4K200104OxylightRaja Trading Company, Inc.202024—
+4K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+4K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+4K151629Guardian 1000Quanta System Spa20150—
+4K150752GME ExSys 308Gme (German Medical Engineering) GmbH20159—
+4K142952InMode Diolaze DeviceInmode MD, Ltd.20150—
+4K140120EPIC 10Biolase, Inc.20141—
+4K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+4K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+4K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+4K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+4K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121327Diolase 10SBiolase Technology, Inc.20132—