# K124003: Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and Aspirating Laser Probes, Med-Fibe - Pathway: 510(k) (Traditional) - Applicant: Med-Fibers, Inc. - Decided: Jan 17, 2013 after 22 days - Product code: GEX (Powered Laser Surgical Instrument) - Device class: 2 - Regulation: 21 CFR 878.4810 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 21 generations back to K943450 (1995). 399 ancestors in all. 23 later devices descend from it; 3 cite it directly. 0 of 423 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K972272: Laser Peripherals Holmium Bare Fibers, Laser Peripherals, LLC (1997) Summary page 2. - K011207: Laser Peripherals Reusable Holmium Fiber, Laser Peripherals, LLC (2001) Summary page 2. - K050738: FT Fiber Optic Delivery Systems, Fibertech GmbH (2005) Summary page 2. - K011703: Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices, Lumenis (2001) Summary page 2. - K050108: Sureflex and Accuflex Laser Lithotripsy Fibers, Innovaquartz (2005) Summary page 2. - K934008: Megabeam Lateral Fire Fiber Optic Delivery Syst, Ceram Optec, Inc. (1994) Summary page 2. - K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 2. - K943444: Megabeam Lateral Fire, Ceram Optec, Inc. (1994) Summary page 2. - K943526: Megabeam Lateral Fire Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 2. - K943527: Megabeam Lateral Fire, Ceram Optec, Inc. (1994) Summary page 2. - K941909: Mega Beam Lateral Fire, Hogan & Hartson (1994) Summary page 2. - K110080: Radial-Emitting Shaped Fiber Optic Delivery System, Biolitec, Inc. (2011) Summary page 2. - K113858: Megabeam Endo-Ent Probe, Biolitec Medical Devices, Inc. (2012) Summary page 2. - K113792: Megabeam Endocular Probe and Aspirating Endocular Probe, Biolitec Medical Devices, Inc. (2012) Summary page 2. - K120926: Endobeam Holmium Laser Fibers, C.R. Bard, Inc. (2012) Summary page 2. - K120810: Fiberoptic Laser Delivery System, Fiberoptic Fabrications, Inc. (2012) Summary page 2. - K121127: Sidelaze Laser Beam Delivery Accessory for Cynosure 1440NM Wavelength Lasers, Cynosure, Inc. (2012) Summary page 2. ## Most influential descendants - K170366: Laser Peripherals, LLC Family of Bare Laser Fibers (2017), 13 descendants of its own - K220189: LISA Laser Surgical Fibers (2022), 5 descendants of its own - K140470: Oberon: Laser Surgery Fiber, Atraumatic Surgery Fiber, Side Fire Fiber, Radial Emission Fiber, Dental Surgery Fiber (2014), 5 descendants of its own - K131473: (Quanta System) Surgical Laser Fibers (2013), 5 descendants of its own - K160513: Quanta System Surgical Laser fibers (2016), 3 descendants of its own ## Indications for use The MED-Fibers, surgical fiber optic laser delivery device, Endo-ENT fibers, Side Fire Laser delivery fibers and Endo Probes including Aspirating Endo Probes are intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures including via endoscopes and cystoscopes. The MED-Fibers surgical fiber optic laser delivery device is intended for use with any cleared surgical laser with a SMA 905 connector. In addition cleared lasers with SMA 906 connectors. The MED-Fibers surgical fiber optic laser delivery devices are indicated for use in general surgery applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. (Diode Laser 532nm-2100nm) MED-Fibers, surgical fiber optic laser delivery devices is also intended as an aid for otologic procedures, for use in incision, excision, coagulation and vaporization of soft and fibrous tissue including osseous tissue (Diode Laser 532nm-2000nm). MED-Fibers surgical fiber optic delivery devices are also intended for intraocular photocoagulation with or without simultaneous aspirating/irrigating as an adjunct to vitrectomy surgery. (Diode Laser 532nm-2000nm), Specific indications include the treatment of proliferative vitreoretinopathy, Tractional retinal detachments, proliferative diabetic retinopathy and various vascular tumors (Diode Laser 532nm-2100nm) MED-Fibers surgical fiber optic delivery device is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho;YAG, Nd;YAG, 1.44YAG and Diode Lasers (532nm-2100nm) with peak and continuous power from 1 - 300 Watt. MED-Fibers surgical laser fibers is indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT/otolaryngology, endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with an approved compatible laser marketed for use in the desired application. Source page: https://510kreport.com/device/K124003 Methodology: https://510kreport.com/methodology