510(k) Report

Devices descending from K974586

318 later devices reach Aurora Diode Laser System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd.20252—
+8K250206Diode laser system (Night Universe; Predator)Ivylaser (Beijing) Technology Co.,Ltd20250—
+8K241656Eneka SelectifTermosalud20241—
+8K241600DermablateAsclepion Laser Technologies GmbH20240—
+8K240611IVYLASER Diode laser hair removal system (IVY-HR-Alloy)Ivylaser (Beijing) Technology Co.,Ltd20240—
+8K240816MeDioStarAsclepion Laser Technologies GmbH20240—
+8K234057NirvanaEl.En S.P.A.20240—
+8K233024Alma HarmonyAlma Lasers, Inc.20241—
+8K232236EchoQuanta System Spa20230—
+8K231054V-LaserWontech Co., Ltd.20231—
+8K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd.20231—
+8K230580Diode Laser SystemSmedtrum Medical Technology Co., Ltd.20230—
+8K230371The Alma Soprano TitaniumAlma Lasers, Inc.20232—
+8K223540AvalancheLase FamilyFotona D.O.O.20230—
+8K213267Dynamis Pro FamilyFotona D.O.O.20222—
+8K221571InMode Multi-systemInMode, Ltd.20222—
+8K213350mJOULE System and AccessoriesSciton, Inc20220—
+8K202288FinebeamSNJ Co., Ltd.20212—
+8K212607DarwinLuvo Medical Technologies, Inc.20210—
+8K212270DEKA LipoAIEl.En Electronic Engineering Spa20210—
+8K203788DermaV Laser SystemLutronic Corporation202101
+8K202985LightWalker Laser System FamilyFotona D.O.O.20217—
+8K202172StarWalkerFotona D.O.O.20203—
+8K192856MT OneM&T S.R.L.20202—
+8K193661LightWalker Laser System FamilyFotona D.O.O.20208—
+8K192539Deka LuxeaEl.En Electronic Engineering Spa20194—
+8K191942MT One DiamondM&T S.R.L.20191—
+8K183156V-LaserWontech Co., Ltd.20193—
+8K181518Sebacia MicroparticlesSebacia, Inc.20180—
+8K172413MT ONEM&T S.R.L.20175—
+8K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Alma Lasers, Inc.201724—
+8K152722neoV980 & neoV1470 Diode LasersG.N.S Neolaser, Ltd.201517—
+8K133774AtovenBio-Med USA, Inc.20146—
+8K113504Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa201312—
+8K112013Evolve (R) HPD 980/1470NM Multiwavelength Diode LaserBiolitec, Inc.20126—
+8K100726Ceralas D/ 980NM Fiber-Coupled Diode Laser Family, Ceralas E/ 980NM Fiber-Coupled Diode…Biolitec, Inc.201054—
+8K100558Quanta Diode Laser SystemQuanta System Spa201068—
+9K252723Dynamis Pro FamilyFotona D.O.O.20260—
+9K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K261964Echolaser X4Elesta S.P.A20260—
+9K260256Q-Switched Nd: YAG Laser SystemsShanghai Apolo Medical Technology Co., Ltd.20260—
+9K253342PICO-KSpeclipse, Inc.20251—
+9K253344Bellus-QSpeclipse, Inc.20250—
+9K251049SurgiLight 1470 Diode Laser System (Model:Halo)Micro-Energy Medical Technology Co., Ltd.20250—
+9K251632Optimas MAX SystemInMode, Ltd.20251—
+9K251094Alma VeilWontech Co., Ltd.20250—
+9K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+9K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+9K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+9K240747Medical Diode Laser (M2-GK)Wuhan Pioon Technology Co., Ltd.20244—
+9K240644Medical Diode Laser (S1Pro)Wuhan Pioon Technology Co., Ltd.20242—
+9K233344Regenalase Laser SystemIpg Medical20240—
+9K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+9K222701MANTA LaserSqualus Med, Ltd.20222—
+9K22079410PLTentech Co., Ltd.20220—
+9K221427V-LaserWontech Co., Ltd.20222—
+9K212790XLase PlusBiotec Italia, Srl20220—
+9K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K200736Stardust MedI.T.S. Group S.R.L.20200—
+9K200616E>EyeCE-Swin20200—
+9K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+9K181867Deka Smartxide2 TrioEl.En Electronic Engineering Spa20180—
+9K160952Alma Diode Tabletop LaserAlma, Ltd.20165—
+9K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking…Ninepoint Medical, Inc.20162—
+9K133895Deka Smartxide Laser SystemEl.En S.P.A.201410—
+9K140005Alma Diode Tabletop LaserAlma Lasers, Ltd.20146—
+9K133006Neov Diode Laser FamilyG.N.S Neolaser, Ltd.201413—
+9K121327Diolase 10SBiolase Technology, Inc.20132—
+9K120437Twister Side-Fire Fiber Optic Delivery SystemBiolitec Sia (Latvia)20120—
+9K120231Evolve HPD 980/ 1470NM Multiwavelength Diode Laser (Evolve Dual)Biolitec Medical Devices, Inc.20124—
+9K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc.201126—
+9K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc.201046—
+10K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+10K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+10K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+10K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd.20205—
+10K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+10K162169EdgeOne CO2 LaserJeisys Medical, Inc.20167—
+10K150587Cortex Laser SystemCynosure, Inc. Dba Ellman20151—
+10K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+10K130465EPIC 10SBiolase Technology, Inc.20130—
+10K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+10K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+10K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+11K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+11K260974CO2 Laser Machine (Monica-I,Monica-II)Nanjing Bestview Laser S&T Co., Ltd.20260—
+11K251730LIA Console (542-7)Leadoptik, Inc.20250—
+11K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+11K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+11K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+11K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+11K202041Opera EvoQuanta System Spa20200—
+11K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+11K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+11K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+11K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+11K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+12K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+12K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+12K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—