510(k) Report

Devices descending from K993002

179 later devices reach Ceralas D 980NM Diode Laser System, Model D15 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082938EzlaseBiolase Technology, Inc.200850—
+1K072779Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.2008153—
+1K031819Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd.20030—
+2K140120EPIC 10Biolase, Inc.20141—
+2K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+2K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+2K121286EPIC 10Biolase Technology, Inc.201231—
+2K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+2K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+2K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+2K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+2K081352Profile Multi-Platform SystemSciton, Inc2008112—
+2K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+2K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+3K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+3K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+3K192430Epic 980Biolase, Inc.20195—
+3K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+3K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+3K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+3K173285Joule SystemSciton, Inc20185—
+3K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+3K170500SIROLaser Advance+Dentsply Sirona201721—
+3K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+3K161185LUCERNA Dental LaserViax Dental Lab20160—
+3K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+3K142226Pilot Ultra Diode LaserCAO Group, Inc.20140—
+3K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+3K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+3K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K094049Stlase Diode LaserDental Photonics, Inc.201023—
+3K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+3K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+3K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+4K254197Picasso Pro Diode Laser (002-00460)CAO Group, Inc.20260—
+4K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+4K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+4K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+4K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+4K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+4K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+4K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+4K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+4K213761Joule diVa SystemSciton, Inc20220—
+4K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+4K200693K2 MobileHulaser, Inc.20202—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193486Epic 980Biolase, Inc.20202—
+4K181614Sterling Supreme Diode LaserCAO Group, Inc.20190—
+4K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+4K180508Joule SystemSciton, Inc20183—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+4K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+4K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+4K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+4K132976AdvatxAdvalight Aps20141—
+4K111689StlaseDental Photonics, Inc.201222—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+5K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+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—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)Wuhan Pioon Technology Co., Ltd.20250—
+5K250189AdvaTxAdvalight Aps20250—
+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—
+5K234085LUNE™ PureHygieneEnamel Pure20241—
+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—
+5K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+5K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+5K210183Waterlase iPLusBiolase, Inc.20220—
+5K210847UltraClear Fractional Laser SystemFa International, LP20210—
+5K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—
+5K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+5K193367elysion-proHigh Technology Products S.L.U20203—
+5K193446Bare: 808Luvo Medical Technologies, Inc.20202—
+5K191321Primelase ExcellenceHigh Technology Products S.L.U20198—
+5K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc.201822—
+5K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+5K163128Epic ProBiolase, Inc.201716—
+5K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH20156—
+5K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.201562—
+5K141237Harmony LiteAlma, Inc.20154—
+5K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH201532—
+5K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+6K260138LUNE PureHygieneEnamel Pure20260—
+6K252599Diode Laser Therapy Systems (WLA-02)Wingderm Electro-Optics, Ltd.20260—
+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—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K230308Alma HarmonyAlma Lasers, Inc.20232—