510(k) Report

Devices descending from K951775

300 later devices reach Ceralas Diode Laser System (Model Ceralas D50) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050738FT Fiber Optic Delivery SystemsFibertech GmbH20052255
+1K983058Ceralas D Laser System, Model # Ceralas D15Ceram Optec, Inc.1998208—
+1K981126Ceralas G Frequency Doubled ND: Yag Laser Systems, Ceralas G3Ceram Optec, Inc.19980—
+1K980838Reusable Megabeam Fiber Optic Delivery SystemCeram Optec, Inc.19981—
+2K140366Endlessfiber Reusable Surgical Laser FiberHogue Surgical, LLC20141—
+2K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+2K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+2K113688Megabeam Reusable Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20120—
+2K092660Sirolaser AdvanceSirona Dental Systems GmbH200927—
+2K090281Accutech Family of Powerflex Laser Delivery DevicesAccutech Medical Technologies, Inc.20090—
+2K072779Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.2008153—
+2K072262Gentleray 980 Diode Laser SystemKavo America200751—
+2K060033Profile Multi-Platform SystemSciton, Inc2006221—
+2K053161SirolaserSirona Dental Systems GmbH200679—
+2K031819Dio-Dent 10 Dental Diode LaserMsq (M2), Ltd.20030—
+2K991891Ceralas Diode Laser System, Model Ceralas D15Ceram Optec, Inc.1999207—
+3K213761Joule diVa SystemSciton, Inc20220—
+3K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+3K163197Cook Holmium Laser FiberCook Incorporated20170—
+3K152667ATOVEN-Reusable Laser FiberDiotech CO20160—
+3K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+3K141975Waterlase Iplus SBiolase, Inc.20150—
+3K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+3K140120EPIC 10Biolase, Inc.20141—
+3K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc.20130—
+3K113489ORIONAsclepion Laser Technologies GmbH20120—
+3K101916Joule Multi-Platform SystemSciton, Inc2011111—
+3K103753Sirolaser Advance, Sirolaser Xtend, Sirolaser Xtend Upgraded, FonalaserSirona Dental Systems GmbH201126—
+3K102669Diode Laser Therapy SystemChina Daheng Group, Inc.20101—
+3K102036Doctor Surgery Diode Lasers FamilyLambda S.P.A.20107—
+3K094049Stlase Diode LaserDental Photonics, Inc.201023—
+3K093087BWF-5 Medical Laser SeriesLitecure, LLC20100—
+3K100474Quicklasedual+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 Model: 3W,5W,3W,5WQuicklase Limited20108—
+3K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+3K082721Laserpro 810, 940 and 980 Diode Laser SystemsPhoto Medex, Inc.200871
+3K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+3K081352Profile Multi-Platform SystemSciton, Inc2008112—
+3K081015Ceralas D 980NM Diode Laser, Models D15 and D25Biolitec, Inc.200834—
+3K073411LiteduoLight Instruments20081—
+3K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810—
+3K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc.2008202—
+3K070388Profile Multi-Platform SystemSciton, Inc2007129—
+3K070138Cutera ER:Yag Laser HandpieceCutera, Inc.20071—
+3K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+3K062258Genesis Diode LaserIvoclar Vivadent, Inc.200771—
+3K063384Diodent Micro Dental Laser System, Models 810 and 980Hoya Conbio, Inc.200713—
+4K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+4K243141Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser…Jiangxi Medex Technology Co., Ltd.20240—
+4K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+4K232106Air Gap FiberWontech Co., Ltd.20240—
+4K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+4K212733Diode laser therapy deviceBeijing Star New Tech Co., Ltd.20230—
+4K212734Diode laser therapy deviceTriangel Rsd Limited20235—
+4K214008Dental diode laserShenzhen Soga Technology Co., Ltd.20220—
+4K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+4K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+4K193656SkyPulseFotona D.O.O.202011—
+4K193486Epic 980Biolase, Inc.20202—
+4K200234Surgical laser fibersQuanta System Spa20202—
+4K180044SIROLaser BlueDentsply Sirona201812—
+4K173285Joule SystemSciton, Inc20185—
+4K170500SIROLaser Advance+Dentsply Sirona201721—
+4K163638Dental 5 Multi Diode laserBio-Med USA, Inc.20170—
+4K161185LUCERNA Dental LaserViax Dental Lab20160—
+4K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+4K151890Medical Diode Laser SystemsWuhan Gigaa Optronics Technology Co., Ltd.20153—
+4K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+4K152032ELUMI 810 + 980 Soft Tissue LaserAzena Medical, LLC20157—
+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—
+4K131839DC 7Dc International, LLC20130—
+4K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+4K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+4K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+4K111689StlaseDental Photonics, Inc.201222—
+4K110364Dornier Medilas D Litebeam+ 1470Dornier Medtech America, Inc.20117—
+4K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+4K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+4K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+4K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+4K101573Accusculpt II Laser SystemLutronic Corporation20101—
+4K101152Naturalase Diode Laser Family Naturalase Model NL980, Naturalase Diode Laser Family…Focus Medical, LLC20100—
+4K093048D-Storm 810NM, D-Storm 980NMLight Instruments20100—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+4K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa2008192—
+4K082445CURATIVE980 Diode LaserOroscience, Inc.20080—
+4K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080—
+4K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+4K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080—
+4K073332V-Raser Diode Laser SystemHoya Conbio, Inc.20080—
+5K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+5K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+5K250731MateLaser Medical Diode Laser Systems (ML-DLS-30)Matelaser, Inc.20250—