510(k) Report

Devices descending from K991994

280 later devices reach Twilight through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K083069Ezlase 10WBiolase Technology, Inc.200836—
+1K063384Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc.200713—
+1K012511Waterlase MillenniumBiolase Technology, Inc.2002246—
+2K193656SkyPulseFotona D.O.O.202011—
+2K163638Dental 5 Multi Diode laserBio-Med USA, Inc.20170—
+2K121286EPIC 10Biolase Technology, Inc.201231—
+2K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+2K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+2K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+2K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+2K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+2K052354Oculase MDBiolase Technology, Inc.20065—
+2K030523WaterlaseBiolase Technology, Inc.20048—
+2K021508Opusduo EC Dental Laser SystemOpusdent, Ltd.2002240—
+3K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+3K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+3K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+3K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+3K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+3K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+3K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+3K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+3K200693K2 MobileHulaser, Inc.20202—
+3K193486Epic 980Biolase, Inc.20202—
+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—
+3K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+3K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+3K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+3K081589Waterlase, Version 3.0Biolase Technology, Inc.20081—
+3K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+4K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+4K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+4K234085LUNE™ PureHygieneEnamel Pure20241—
+4K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+4K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+4K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+4K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K132661LightscalpelLightscalpel, LLC20143—
+4K123494SOLEAConvergent Dental, Inc.201331
+4K123004Mira LasersMira Lasers, LLC20130—
+4K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+4K060033Profile Multi-Platform SystemSciton, Inc2006221—
+5K260138LUNE PureHygieneEnamel Pure20260—
+5K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+5K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+5K244060eCO2 3DLutronic Corporation20250—
+5K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+5K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+5K170073LightMed Dental Laser SystemLightmed Dentaltechnology Corp.20170—
+5K151306SoleaConvergent Dental, Inc.20151—
+5K141658Light ScalpelLightscalpel, LLC20142—
+5K130420SOLEAConvergent Dental, Inc.201321
+5K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+5K111831MX-7000 MicroxelBio-Med USA, Inc.20111—
+5K101916Joule Multi-Platform SystemSciton, Inc2011111—
+5K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+5K073411LiteduoLight Instruments20081—
+5K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+6K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+6K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+6K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+6K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+6K213669Lightscalpel LS-4020Lightscalpel, Inc.20230—
+6K221761SoleaConvergent Dental, Inc.202201
+6K173827LightScalpelLightscalpel, LLC20180—
+6K173359Fractional CO2 Surgical Laser SystemAmi, Inc.20180—
+6K173285Joule SystemSciton, Inc20185—
+6K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+6K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+6K132976AdvatxAdvalight Aps20141—
+6K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+6K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+6K101573Accusculpt II Laser SystemLutronic Corporation20101—
+6K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+6K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+6K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+6K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+6K081352Profile Multi-Platform SystemSciton, Inc2008112—
+6K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+6K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+6K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+7K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—