510(k) Report

Devices descending from K030805

363 later devices reach Mythos 500 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+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—
+5K131059Pioneer Elite Diode LaserCAO Group, Inc.20132—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+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—
+5K121286EPIC 10Biolase Technology, Inc.201231—
+5K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+5K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+5K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+5K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+5K112253Ceralas 147NM Diode Laser SystemBiolitec, Inc.201118—
+5K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+5K092734E-Light LineEspansione Marketing S.P.A20102—
+5K094049Stlase Diode LaserDental Photonics, Inc.201023—
+5K091562Doctor Smile a-810 and B-980 LasersLambda Scientific Spa20098—
+5K091059Foxq 980 LaserA.R.C Laser GmbH20090—
+5K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+5K082263Ceralas E 980NM Diode Laser, Models E15/980 and E30/980Biolitec, Inc.20081—
+6K261562Diode Laser Therapy SystemSanhe LEFIS Electronics Co., Ltd.20260—
+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—
+6K242859VEGAIbramed Equipamentos Médicos20250—
+6K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+6K251339Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03…Zhengzhou PZ Laser Slim Technology Co., Ltd.20250—
+6K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+6K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+6K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+6K250189AdvaTxAdvalight Aps20250—
+6K250018Medical Diode Laser Systems (THEIA808)Gigaalaser Company, Ltd.20250—
+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—
+6K241860Diode Laser Hair Removal SystemBeijing Winkonlaser Technology Limited20240—
+6K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+6K241656Eneka SelectifTermosalud20241—
+6K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+6K233344Regenalase Laser SystemIpg Medical20240—
+6K240520Diode Laser Hair Removal System (SH-VD910)Beijing Sea Heart International Science and Technologyco.Ltd20240—
+6K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+6K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+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—
+6K233024Alma HarmonyAlma Lasers, Inc.20241—
+6K232236EchoQuanta System Spa20230—
+6K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+6K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+6K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+6K223778Diode Laser Hair Removal System (RD-SLD600)Shanghai Omni Laser Skinology Co., Ltd.20230—
+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—
+6K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+6K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+6K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+6K222916US 450 Diode Laser EquipmentBeijing Globalipl Development Co., Ltd.20220—
+6K221712Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)Fotona D.O.O.20221—
+6K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+6K221571InMode Multi-systemInMode, Ltd.20222—
+6K210183Waterlase iPLusBiolase, Inc.20220—
+6K212478Dermatological diode laser systemBeijing Stelle Laser Technology Co., Ltd.20220—
+6K213225Diode Laser System GP900A8, Diode Laser System GP900Q8Shenzhen Gsd Tech Co., Ltd.20210—
+6K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+6K212607DarwinLuvo Medical Technologies, Inc.20210—
+6K211335Diode Laser Machine, Model Number: BM-100Zhengzhou Bestview ST Co., Ltd.20215—
+6K202257Dermatological Diode Laser SystemsZhuolu Jontelaser Manufacturing Technology Co., Ltd.20210—
+6K202980Laser Therapy DeviceShenzhen Leaflife Technology Co., Ltd.20202—
+6K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+6K192856MT OneM&T S.R.L.20202—
+6K191970Diode Laser Hair Removal SystemBeijing Sano Laser S&T Development Co.,Ltd20200—
+6K193328IPL + Diode Laser MachineBeijing Globalipl Development Co., Ltd.20200—
+6K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+6K192430Epic 980Biolase, Inc.20195—
+6K191942MT One DiamondM&T S.R.L.20191—
+6K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+6K181601Precise SHP Diode LaserCAO Group, Inc.20191—
+6K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+6K182924Diode Laser Treatment SystemWeifang KM Electronics Co., Ltd.20192—
+6K182604New EraStep UP Skin Laser, LLC201801
+6K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+6K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+6K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+6K180967Dental Diode Laser SystemLazon Medical Laser Co., Ltd.20180—
+6K180508Joule SystemSciton, Inc20183—
+6K180353Diode laser hair removal deviceZhengzhou PZ Laser Slim Technology Co., Ltd.201824—
+6K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+6K1730022940 nm Er:Yag Laser HandpieceQuanta System Spa20171—
+6K171702Exciplex308nmClarteis20175—
+6K172413MT ONEM&T S.R.L.20175—
+6K171986Sterling Supreme Diode LaserCAO Group, Inc.20171—
+6K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+6K170500SIROLaser Advance+Dentsply Sirona201721—
+6K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc.20163—
+6K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—