510(k) Report

Devices descending from K053161

79 later devices reach Sirolaser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+1K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+1K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+1K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+1K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+1K073411LiteduoLight Instruments20081—
+1K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+1K063384Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc.200713—
+2K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+2K193486Epic 980Biolase, Inc.20202—
+2K163638Dental 5 Multi Diode laserBio-Med USA, Inc.20170—
+2K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+2K131839DC 7Dc International, LLC20130—
+2K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+2K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+2K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+2K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH201126—
+2K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+2K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+2K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+2K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+2K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+2K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+2K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+3K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+3K234085LUNE™ PureHygieneEnamel Pure20241—
+3K214008Dental diode laserShenzhen Soga Technology Co., Ltd.20220—
+3K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+3K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+3K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+3K180044SIROLaser BlueDentsply Sirona201812—
+3K170500SIROLaser Advance+Dentsply Sirona201721—
+3K161185LUCERNA Dental LaserViax Dental Lab20160—
+3K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+3K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+3K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+3K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+3K102639SL3Discus Dental, LLC201011
+3K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+4K260138LUNE PureHygieneEnamel Pure20260—
+4K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+4K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+4K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+4K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+4K200693K2 MobileHulaser, Inc.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+4K123004Mira LasersMira Lasers, LLC20130—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+5K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+5K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+5K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+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—
+5K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+5K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+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—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K192430Epic 980Biolase, Inc.20195—
+5K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+6K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+6K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—