510(k) Report

Devices descending from K023547

52 later devices reach Diolase 980 D Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K072262Gentleray 980 Diode Laser SystemKavo America200751—
+2K113489ORIONAsclepion Laser Technologies GmbH20120—
+2K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+2K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+2K094049Stlase Diode LaserDental Photonics, Inc.201023—
+2K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+2K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+3K131839DC 7Dc International, LLC20130—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K111689StlaseDental Photonics, Inc.201222—
+3K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH201126—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K214008Dental diode laserShenzhen Soga Technology Co., Ltd.20220—
+4K193486Epic 980Biolase, Inc.20202—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K163128Epic ProBiolase, Inc.201716—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+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—
+5K234085LUNE™ PureHygieneEnamel Pure20241—
+5K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+5K210350Gemini 2 810+980 Soft Tissue LaserAzena Medical, LLC20211—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K193656SkyPulseFotona D.O.O.202011—
+5K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+5K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+5K172771Epic Pro 940Biolase, Inc.20171—
+5K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K260138LUNE PureHygieneEnamel Pure20260—
+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—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K230047Medical Diode Laser SystemsGigaalaser Company, Ltd.20242—
+6K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K200693K2 MobileHulaser, Inc.20202—
+7K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+7K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+7K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+7K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE…Gigaalaser Company, Ltd.20251—
+7K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+7K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+8K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight…Wuhan PHOMED Technology Company, Ltd.20260—