510(k) Report

Devices descending from K990219

247 later devices reach Modification of Millennium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+10K253100MultiPulse TFLAsclepion Laser Technologies GmbH20251—
+10K251632Optimas MAX SystemInMode, Ltd.20251—
+10K250465CO2 Laser Machine (Lume)Nanjing Bestview Laser S&T Co., Ltd.20250—
+10K251094Alma VeilWontech Co., Ltd.20250—
+10K243780HELIOS 785 Pico (1754V2)Laseroptek Co., Ltd.20250—
+10K241951Lasya-TrinityBLUECORE COMPANY Co., Ltd.20240—
+10K242202LightWalker Laser System FamilyFotona D.O.O.20241—
+10K232133Co2 Laser System, Models: PureLase And VanLaseCpmt Laser (Canadian Pioneer Medical Technology Corporation)20240—
+10K231896Diode Laser Therapy SystemBeijing Adss Development Co., Ltd.20240—
+10K22079410PLTentech Co., Ltd.20220—
+10K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd.20222—
+10K221427V-LaserWontech Co., Ltd.20222—
+10K212790XLase PlusBiotec Italia, Srl20220—
+10K203395Platform treatment systemShanghai Apolo Medical Technology Co., Ltd.20221—
+10K202041Opera EvoQuanta System Spa20200—
+10K200736Stardust MedI.T.S. Group S.R.L.20200—
+10K200616E>EyeCE-Swin20200—
+10K191162EpiLaze Multi-wavelength LaserRohrer Aesthetics, LLC20190—
+10K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+10K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd20160—
+10K151855SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral…Surgical Laser Incorporated20160—
+10K140470Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission…Oberon GmbH Fiber Technologies20145—
+10K131473(Quanta System) Surgical Laser FibersQuanta System Spa201351
+11K253309SOGA Lasers therapy system family of Aurora handpiece (Aurora-S); SOGA Lasers therapy…Shenzhen Soga Technology Co., Ltd.20260—
+11K261214Pico Shining (Pico-K; Picofy)Speclipse, Inc.20260—
+11K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+11K252215InbellaMAX SystemInbella Medical, Ltd.20250—
+11K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd.20241—
+11K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+11K232106Air Gap FiberWontech Co., Ltd.20240—
+11K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+11K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+11K200234Surgical laser fibersQuanta System Spa20202—
+11K163197Cook Holmium Laser FiberCook Incorporated20170—
+11K160513Quanta System Surgical Laser fibersQuanta System Spa201631
+11K152417Adler MicroMed Laser Surgery FibersAdler Micromed, Inc.20153—
+12K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+12K242941CO2 Laser Therapy Systems (SHE-LSP003-1)Beijing Sano Laser S&T Development Co.,Ltd20250—
+12K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+12K232769BeaMed Laser Surgery FibersBt Beamedical Tachnoogies Ltd. (Beamed)20231—
+12K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+12K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+12K161403A.R.C. Laser Surgical Fibers and ProbesA.R.C Laser GmbH20160—
+13K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+13K253007Laser 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—
+13K250113neoLaser Laser Surgery FibersG.N.S Neolaser, Ltd.20250—
+14K261701Hemolase 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—