510(k) Report

Devices descending from K991297

481 later devices reach Uni-Laser 450P CO2 Laser System & Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K22079410PLTentech Co., Ltd.20220—
+8K221427V-LaserWontech Co., Ltd.20222—
+8K212790XLase PlusBiotec Italia, Srl20220—
+8K212073Alma Diode Tabletop LaserAlma Lasers, Ltd.20220—
+8K212472AgeJetTriworks Group Srl20220—
+8K200736Stardust MedI.T.S. Group S.R.L.20200—
+8K200616E>EyeCE-Swin20200—
+8K200786Venus EpileveVenus Concept USA, Inc.20200—
+8K192350Medical Non-Ablative Fractional Laser SystemsWingderm Electro-Optics, Ltd.202021
+8K193072Lucent : IPLLuvo Medical Technologies, Inc.20203—
+8K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.202012—
+8K191349980nm Diode Laser Therapy DeviceShanghai Apolo Medical Technology Co., Ltd.20190—
+8K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+8K183307Magma Spark Pro (Magma Spark Plus, Alpha)Formatk Systems, Ltd.20180—
+8K182616NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation SystemNinepoint Medical, Inc.20181—
+8K173067LightForce LTS Model 1000, 1500, 2500, and 4000Litecure, LLC20180—
+8K161185LUCERNA Dental LaserViax Dental Lab20160—
+8K152461The Time Machine Series LasersMedical Lasers Manufacturer, Inc.20160—
+8K160195Forma System, Forma Light SystemFormatk Systems, Ltd.20160—
+8K153566Magma SystemFormatk Systems, Ltd.20162—
+8K133891Multipulse TM+1470Asclepion Laser Technologies GmbH20153—
+8K131839DC 7Dc International, LLC20130—
+8K130465EPIC 10SBiolase Technology, Inc.20130—
+8K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc.201323—
+8K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc.201224—
+8K112442Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec Medical Devices, Inc.20110—
+9K254185Potenza PrimeJeisys Medical Incorporated20260—
+9K2615891927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+9K253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.20260—
+9K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.20260—
+9K253484Lutronic GeniusCynosure Lutronic Technology Corporation20260—
+9K253803MILAN SystemLumenis Be, Ltd.20260—
+9K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+9K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+9K253750BTL-785NEHBTL Industries, Inc.20260—
+9K251435InbellaIgnite RF SystemInbella Medical, Inc.20260—
+9K251254Ignite RF SystemInMode, Ltd.20260—
+9K251730LIA Console (542-7)Leadoptik, Inc.20250—
+9K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+9K252367InbellaMulti SystemInbella Medical, Inc.20250—
+9K243123IPL Treatment Device (MDSQMC-01)Medusa (Guangxi)Medical Devices Co., Ltd.20250—
+9K242469RFMagik LiteAgnes Medical Co., Ltd.20252—
+9K250809Stellar M22Lumenis Be, Ltd.20250—
+9K242532BTL-785BNF-EBTL Industries, Inc.20241—
+9K242598DEFINE System (AG612444A)InMode, Ltd.20240—
+9K240314Mula (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., Ltd.20240—
+9K233642InMode RF SystemInMode, Ltd.20244—
+9K222790F65 Laser SystemLumenis Be, Ltd.20233—
+9K221770Fiber Laser Treatment SystemShanghai Apolo Medical Technology Co., Ltd.20221—
+9K202041Opera EvoQuanta System Spa20200—
+9K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+9K162781Magma SparkFormatk Systems, Ltd.20160—
+9K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+9K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+9K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+10K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit20260—
+10K2618211565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.20260—
+10K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+10K250217AGNES UltraAgnes Medical Co., Ltd.20250—
+10K243713Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A…Agnes Medical Co., Ltd.20250—
+10K242349FoLixLumenis Be, Ltd.20240—
+10K240780InMode RF SystemInMode, Ltd.20243—
+10K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+10K232106Air Gap FiberWontech Co., Ltd.20240—
+10K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+10K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+10K200234Surgical laser fibersQuanta System Spa20202—
+10K163197Cook Holmium Laser FiberCook Incorporated20170—
+10K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+10K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+11K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+11K243737Inbella RF SystemInbella Medical, Inc.20250—
+11K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+11K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+11K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+11K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+11K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+12K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+12K253007Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber…Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.20250—
+12K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+13K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.20260—