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510(k) Data Aggregation

    K Number
    K050541
    Device Name
    OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIVERY
    Manufacturer
    OMNIGUIDE COMMUNICATIONS, INC.
    Date Cleared
    2005-05-09

    (68 days)

    Product Code
    HQF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    OMNIGUIDE COMMUNICATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral / maxillofacial surgery, dentistry, dermatology, endoscopic and open surgical procedures related to gynecology, otorhinolaryngology, gastroenterology, neurosurgery, pulmonary surgery for surgical and aesthetic applications. The indications for use for which the delivery system is used are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached
    Device Description
    The OmniGuide BeamPath CO2 Mark I Laser Beam Delivery System is an accessory for CO2 laser systems that can be retrofitted to Luxar LX-20 or Lumenis NovaPulse laser systems. It consists of an adapter and a fiber assembly that propagate CO2 laser beams. The OmniGuide BeamPath CO2 Mark I Fiber Assembly is supplied sterile and is intended for single procedure use.
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