510(k) Report

Devices descending from K142638

15 later devices reach ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180140ProFlex Laser FibersInnovaquartz, LLC20180—
+1K170366Laser Peripherals, LLC Family of Bare Laser FibersLaser Peripherals, LLC201713—
+2K250776Lithoblast Single Use Holmium Laser FibersDawell Medical, LLC20250—
+2K233157VaporMAX LDD; MOJo LDD; MegaJOULE LDDInnovaquartz, LLC20240—
+2K232106Air Gap FiberWontech Co., Ltd.20240—
+2K220189LISA Laser Surgical FibersOmni-Guide Holdings, Inc.20225—
+2K201171LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe DisposableLeoni Fiber Optics, Inc.20210—
+2K200234Surgical laser fibersQuanta System Spa20202—
+3K241643WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)Wontech Co., Ltd.20252—
+3K243147LGO-Surgical Laser FibersLight Guide Optics International, Ltd.20241—
+3K230819OmniGuide RFID Surgical Laser FibersOmni-Guide Holdings, Inc.20230—
+3K220793InnoVoyce Laser FiberInnovoyce, LLC20220—
+4K252745Halo Sterile Single-use Radial Fiber…Micro-Energy Medical Technology Co., Ltd.20251—
+4K253007Laser 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—
+5K261701Hemolase 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—