510(k) Report

Devices descending from K964760

908 later devices reach Dornier Medilas Fiber Tome Laser through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+5K141063Linscan 808, Linscan 980Gme (German Medical Engineering) GmbH20145—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+5K132976AdvatxAdvalight Aps20141—
+5K140503Flexiva SF Side-Firing Single-Use Laser FiberBoston Scientific20140—
+5K132975Sphinx JRAllmed Systems, Inc.20141—
+5K140388Lumenis Pulse 120HLumenis, Ltd.201434—
+5K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+5K122567Joule 810/940/980 Multi-Platform SystemSciton, Inc20136—
+5K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+5K121327Diolase 10SBiolase Technology, Inc.20132—
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K113018Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based PlatformBeijing Syntech Laser CO., LTD.20121—
+5K121938Medilas H Rfid Laser FiberDornier Medtech America, Inc.20123—
+5K120926Endobeam Holmium Laser FibersC.R. Bard, Inc.201224—
+5K113810Modified Alma Lasers Harmony 1064NM (ND:Yag) ModulesAlma Lasers, Inc.201234—
+5K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+5K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd.201156—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+5K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+5K100586Venus Freeze SystemVenus Concept, Ltd.201031—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+5K100228Versapulse Model P20 Laser SystemLumenis, Inc.20101—
+5K100078Modified Straight Fire Laser FiberBoston Scientific Corp20105—
+5K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+5K093465Fusion SystemEclipsemed Global, Inc.20100—
+5K083461Imagine TC Skin Therapy SystemEndymion Medical, Ltd.2009101—
+5K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+5K083616Patholase Family of Pinpointe and Pinpointe Footlaser ND: Yag LasersPatholase, Inc.2009136—
+5K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc.2009198—
+5K083215Incisive Family of Inpulse ND:Yag LasersIncisive, LLC2009136—
+5K082039Synchro HP PlatformEl.En Electronic Engineering Spa200919—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+5K082938EzlaseBiolase Technology, Inc.200850—
+5K082876Beamax/ Formax Pulsed Light Device FamilySharplight Technologies, Ltd.200857—
+5K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+5K082928Straight Fire Holmium Laser FiberBoston Scientific Corp20086—
+5K072182Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd.20083—
+5K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+5K070388Profile Multi-Platform SystemSciton, Inc2007129—
+5K070004AccentAlma Lasers, Ltd.2007181—
+5K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006133—
+5K051214Aluma Skin Renewal SystemLumenis, Inc.2005476—
+5K050412VapormaxTrimedyne, Inc.20052—
+5K041959Polaris DS/CometSyneron Medical, Ltd.2004301—
+5K014290Entec Plasma WandsArthrocare Corp.2002119—
+6K260765Gemini NOVA 810+980 Soft Tissue LaserAzena Medical, LLC20260—
+6K252561BTL-754FFBTL Industries, Inc.20260—
+6K251077JOULE 1064nm System and AccessoriesSciton, Inc20250—
+6K252658Medical Diode Laser Systems (TR-B)Baoding Te'Anzhou Electronic Technology Co., Ltd.20251—
+6K252063Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N)…Wuhan Dimed Laser Technology Co., Ltd.20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K242996EndyMed PRO MAXEndymed Medical, Ltd.20251—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K241791Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D…Gigaalaser Company, Ltd.20251—
+6K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+6K234004Medical diode laser systems (CHARISMA, REGAL)Reveal Lasers, Ltd.20251—
+6K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+6K231948MediyagMedicreations, LLC20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240474Multi-function Platform Systems (BL-M10)Shanghai Bele Medical Technology Co.,Ltd20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K234057NirvanaEl.En S.P.A.20240—
+6K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+6K240179Medical Diode Laser (Model: L2)Wuhan Pioon Technology Co., Ltd.20242—
+6K221766SolonLmg Lasers Comercio, Importacao E Exportacao Ltda20240—
+6K233304Omnimax S3, Omnimax S4Sharplight Technologies, Ltd.20230—
+6K232716Q-Switched Nd:Yag laserHebei Zhemai Technology Co., Ltd.20231—
+6K232222Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo)Medency S.R.L.20230—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K231054V-LaserWontech Co., Ltd.20231—
+6K230274Medical Diode Laser (M2)Wuhan Pioon Technology Co., Ltd.20232—
+6K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K223540AvalancheLase FamilyFotona D.O.O.20230—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K22079410PLTentech Co., Ltd.20220—
+6K222800Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone…Sanhe Laserconn Tech Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K213267Dynamis Pro FamilyFotona D.O.O.20222—
+6K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+6K212790XLase PlusBiotec Italia, Srl20220—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K211534RevoLix HTLLisa Laser Products GmbH20220—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K213350mJOULE System and AccessoriesSciton, Inc20220—
+6K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH20223—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K203728DarwinLuvo Medical Technologies, Inc.20211—
+6K202991Fotona XPulse Pro Laser PlatformFotona D.O.O.20213—