510(k) Report

Devices descending from K050453

86 later devices reach Odyssey 2.4G, Denlaser Elite, Model 002-00050 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160413Sterling 5W Diode LaserCAO Group, Inc.20160—
+1K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+1K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+1K083142Picasso Laser SystemAmd Lasers, LLC200916—
+1K083034Fotona XD-2 Diode Laser System, Model MD01-2FFotona D.D.200913—
+1K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+1K062619Denlaser 800 PlusCAO Group, Inc.200640—
+1K062074Iridex Wireless FootswitchIridex Corp20060—
+1K062071Prometey, Model G1-03Spectrum International200617—
+2K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+2K193656SkyPulseFotona D.O.O.202011—
+2K161185LUCERNA Dental LaserViax Dental Lab20160—
+2K152939Picasso Plus, Picasso Lite PlusAmd Group, LLC201512—
+2K142223Pilot Pro Diode LaserCAO Group, Inc.20140—
+2K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+2K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+2K123004Mira LasersMira Lasers, LLC20130—
+2K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+2K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+2K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+2K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+2K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+2K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+2K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+2K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+2K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+2K071896Fox 940, Model 940Valam, Inc.20080—
+2K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+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—
+3K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+3K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+3K193486Epic 980Biolase, Inc.20202—
+3K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+3K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+3K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+3K131839DC 7Dc International, LLC20130—
+3K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+3K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH201126—
+3K102639SL3Discus Dental, LLC201011
+3K093852Ezlase 3 Laser SystemBiolase Technology, Inc.201035—
+3K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+3K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+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—
+4K211150Dental diode laser, SOGA Laser, ILaser IIShenzhen Soga Technology Co., Ltd.20220—
+4K214008Dental diode laserShenzhen Soga Technology Co., Ltd.20220—
+4K200693K2 MobileHulaser, Inc.20202—
+4K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+4K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+4K121286EPIC 10Biolase Technology, Inc.201231—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K260138LUNE PureHygieneEnamel Pure20260—
+5K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+5K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—
+5K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+5K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+5K192430Epic 980Biolase, Inc.20195—
+5K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+6K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+7K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+8K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—