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510(k) Data Aggregation
K Number
K050541Device 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
886.4390Why 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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