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510(k) Data Aggregation

    K Number
    K232769
    Device Name
    BeaMed Laser Surgery Fibers
    Manufacturer
    BT BeaMedical Tachnoogies Ltd. (BeaMed)
    Date Cleared
    2023-12-06

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BT BeaMedical Tachnoogies Ltd. (BeaMed)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BeaMed Laser Surgery Fibers are indicated for use in general surgical applications for incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue, 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. The BeaMed Laser Surgery Fibers have a wavelength range of 450 nm to 2100 nm, can be used in contact and non-contact mode and are indicated for use in general surgery, urology, gastroenterology, gynecology, dermatology, vascular surgery, neurosurgery, plastic surgery, ENT and endovenous occlusion of the greater saphenous vein in the patient with superficial vein reflux and laser assisted lipolysis with a cleared compatible laser marketed for the mentioned intended uses and using an SMA 905 connector.
    Device Description
    The BeaMed Laser Surgery Fibers are sterile, single use, laser delivery devices intended for medical applications in various fields of laser surgery. They are intended to deliver energy to soft tissue in contact and non-contact mode during various surgical applications, including via endoscopes and cytoscopes. The fibers are designed to transmit energy from the laser system to the treatment site, as well as to transmit a low power laser aiming beam to assist in the visibilty of the target tissue.
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