510(k) Report

Devices descending from K954316

382 later devices reach Aurora Surgical Diode Laser System W/Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K123682Inmode Hair Removal (HR) DeviceInmode MD, Ltd.20131—
+4K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+4K121327Diolase 10SBiolase Technology, Inc.20132—
+4K113472Precise SHP Diode LaserCAO Group, Inc.201210—
+4K111689StlaseDental Photonics, Inc.201222—
+4K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+4K113212Dental Laser Therapy SystemChina Daheng Group, Inc.20111—
+4K110243Medart Diode Laser System & AccessoriesMedart A/S20110—
+4K101916Joule Multi-Platform SystemSciton, Inc2011111—
+4K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+4K110079Spphine Plus STM 3W Diode LaserDen-Mat Holdings, LLC20110—
+4K103667Sapphire ST Portable Diode LaserDen-Mat Holdings, LLC20102—
+4K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+4K092734E-Light LineEspansione Marketing S.P.A20102—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.201020—
+4K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010112—
+4K091320Spectra SP II, Spectra Denta IILutronic Corporation200912—
+4K091796Softlase Pro, Ortholase and HygienelaseZap Lasers, LLC20092—
+4K091922Waterlase C100, Model 7100104Biolase Technology, Inc.20090—
+4K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc.2009177—
+4K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090—
+4K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009121—
+4K082938EzlaseBiolase Technology, Inc.200850—
+4K081589Waterlase, Version 3.0Biolase Technology, Inc.20081—
+4K081416Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20089—
+4K081214Styla Microlaser and StylaorthoZap Lasers, LLC200850—
+4K073322Fox 1-980, Fox Q-1064, Fox-Q-810A.R.C Laser GmbH200822—
+4K070296Visiolite Ophthalmic ER: Yag Laser SystemAce Vision Group20070—
+4K063867Cutera ER:Ysgg Laser HandpieceCutera, Inc.20072—
+4K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd.2004226—
+5K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.20260—
+5K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)Wuhan Pioon Technology Co., Ltd.20260—
+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—
+5K251699The Botticelli (Model: Athena)Bellamia Technologies, Inc.20250—
+5K250261Heager Medical Laser Family (Sabrina/Adolf)Heager GmbH20250—
+5K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+5K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)Wuhan Pioon Technology Co., Ltd.20250—
+5K243993Photon Therapy Apparatus (BL-10)Xemis Medical Technology (Shenzhen) Co., Ltd.20250—
+5K243037Diode Laser System model Dawn-SShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K241771Liftendo; Liftendo 2.0Medical San Indústria DE Equipamentos Médicos Ltda.20240—
+5K233344Regenalase Laser SystemIpg Medical20240—
+5K233803UltraClear Laser System (N/A)Acclaro Corporation20241—
+5K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd.202416—
+5K234085LUNE™ PureHygieneEnamel Pure20241—
+5K232885Dawn Diode Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20240—
+5K230342Phototherapy System (OL-PDT950)Shanghai Omni Laser Skinology Co., Ltd.20230—
+5K221623FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nmGme German Medical Engineering GmbH20230—
+5K222751LED Light Therapy Device, KN-7000LXuzhou Kernel Medical Equipment Co., Ltd.202311—
+5K213105Epilaser AbsoluteEpilady 2000, LLC20221—
+5K220531Fox 810, Fox 980A.R.C Laser GmbH20220—
+5K213761Joule diVa SystemSciton, Inc20220—
+5K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+5K210367D-Laser Blue, D-Laser 16Guilin Woodpecker Medical Instrument Co., Ltd.20226—
+5K202175OxyLight 2.0Raja Trading Company, Inc.20211—
+5K201387Ultrafast, Ultrafast Plus, Ultrafast LiteDentlight, Inc.20210—
+5K192617Gemini 810+980 Soft Tissue LaserAzena Medical, LLC20202—
+5K181602Pioneer Elite Diode LaserCAO Group, Inc.20190—
+5K191611Diode Laser Therapy SystemsWingderm Electro-Optics, Ltd.201901
+5K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+5K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+5K172273308nm Excimer SystemChongqing Peninsula Medical Technology Co., Ltd.20185—
+5K180518GME LinScan Lite 808 Laser SystemGme German Medical Engineering GmbH20181—
+5K180508Joule SystemSciton, Inc20183—
+5K171702Exciplex308nmClarteis20175—
+5K163128Epic ProBiolase, Inc.201716—
+5K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+5K142225Pilot Elite Diode LaserCAO Group, Inc.20140—
+5K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+5K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457—
+5K141838Sol Portable Diode Laser Unit (with Wireless Foot Control)Regulatory Technology Services, LLC20140—
+5K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470—
+5K132976AdvatxAdvalight Aps20141—
+5K132661LightscalpelLightscalpel, LLC20143—
+5K124064Young AgainEspansione Marketing S.P.A20131—
+5K123443Precise SHP Diode LaserCAO Group, Inc.20139—
+5K122020Photon Photon PlusZolar Technology & Mfg Co., Inc.20134—
+5K130465EPIC 10SBiolase Technology, Inc.20130—
+5K123494SOLEAConvergent Dental, Inc.201331
+5K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+5K123004Mira LasersMira Lasers, LLC20130—
+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—
+5K100610Lutronic Corporation ECO2 Plus, Denta Iii and Iii+ and SP Iii Laser SystemsLutronic Corporation20113—
+5K102639SL3Discus Dental, LLC201011
+5K080530Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc.20081—
+5K061966Litetouch Dental Laser SystemLight Instrument, Ltd.20063—
+5K060033Profile Multi-Platform SystemSciton, Inc2006221—
+6K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.20260—
+6K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)Shenzhen Kaiyan Medical Equipment Co., Ltd.20260—
+6K260138LUNE PureHygieneEnamel Pure20260—
+6K253245Boston 2910 (Boston 2910)Boston Aesthetics, Inc.20260—
+6K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+6K251730LIA Console (542-7)Leadoptik, Inc.20250—
+6K252994LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7…Guangdong Ace-Tec Co., Ltd.20250—
+6K251825Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG)Shenzhen Ulike Smart Electronics Co., Ltd.20250—