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The OmniGuide Beam Path OTO-U Fiber for CO2 Laser Systems is indicated for the incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissue. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry , dermatology, gynecology, gastroenterology, neurosurgery, urology and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngology, gastroscopy, colonoscopy, laproscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

The OmniGuide Beam Path OTO-U Fiber is a single use laser surgical instrument provided sterile for use in transmitting laser energy at 10.6 µm from a CO2 Laser System to a surgical site through an endoscope, flexible or rigid or using an accessory handpiece. It is connected to the laser system utilizing a standard ST II stainless steel fitting which is used by many laser manufacturers. The fiber has the following dimensions and composition: Component | Dimensions | Material | Body Contact ---|---|---|--- ST II Laser Connector | 17 mm L | Stainless Steel | No Connector Insert (Ferrule) | 128μm | Die Cast Stainless Steel | No RFID Wing | 1.18" W x 0.510"H x 0.512"D | Hytrel 6356 | No SMA Medical Boot | 3.0 mm OD | USP Class IV Plastic | No Fused Silica Core | 600 ± 15μm OD | Silica | Yes Silver Coated Bore | 315 ± 10μm ID | Silver | Yes Hard Clad Buffer | 630 ± 15μm OD | Fluorinated Acrylate | Yes Tefzel Jacket | 1350 ± 70μm OD | Tefzel | Yes The device consists of an optical fiber assembly. The main functional characteristic is a Silver coating reflector that reflects and thereby contains and guides CO2 laser energy within the fiber. Silver coating is applied along the ID of the cladded fused silica core, allowing 10.6 µm laser energy to be guided along the fiber length and onto a surgical location. The fused silica core is cladded with a thin layer of Fluorinated Acrylate. The core is sheathed with a Tefzel polymer layer. Helium gas is flowed in the core to provide cooling of the fiber as needed and to prevent contamination of the fiber core. The fiber assembly is 1 to 2 meters long and transmits at the CO2 laser emission of 10.6 µm. The fiber can be used in single pulse mode, repeat pulse mode and CW mode. Power output is limited to 10 Watts. The recommended distance between fiber tip and tissue is 3 mm and the recommended gas flow is less than 1 liters per minute.

The OmniGuide® TRIO™ handpiece is indicated for the electrosurgical coagulation of soft body tissues and suction of fluids in general and ENT surgical procedures for the specialties of General Surgery, Head and Neck Surgery, Otolaryngology, and Oral surgery (including intra-oral tissues). When used with the OmniGuide® Laser waveguide, it is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues for the added specialties of Dermatology, Neurosurgery, Orthopedic Surgery, Plastic & Reconstructive Surgery, Podiatry and Urology.

The TRIO™ handpiece is a handheld single use device designed to act as a laser waveguide guide/holder for previously cleared waveguides. The TRIO™ handpiece combines three fundamental surgical instrument functions into one lightweight and compact handheld disposable surgical instrument. If enables a surgeon to provide fluid suction, bipolar cautery, and CO2 laser energy without the necessity of changing instruments, saving surgical time for both physician and patient and a corresponding reduction in cost. Laser energy is delivered via a flexible OmniGuide® fiber for minimally invasive surgery. The instrument is provided sterile and is intended for single use only. The package has an accelerated shelf life of two years. The sterile package includes a cable to connect the handpiece to an electrosurgical generator. The cables are generic in nature and several varieties available at a hospital/ office will function. The package also includes a small brush for cleaning coagulation tips with adhered material. The TRIO™ handpiece is intended to be used only with the family of OmniGuide® CO2 Laser fibers including Velocity™, Elite™ and Select™ fibers previously cleared in 510(k) K070157. The OmniGuide® handpiece is intended for use by licensed surgeons only for open surgical procedures listed in the indications for use. The objective of the handpiece is to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the handpiece and fixated so that it is observed at the handpiece's distal tip. The surgeon wields the handpiece as a pencil and advances the handpiece so that its distal tip is near the target tissue to exert the desired effect of the waveguide fiber: suction and coagulation. The surgeon may use the handpiece distal tip in either non-contact mode or contact mode and may use the distal tip to enable tissue manipulation, electrosurgical portion is used for coagulation due to bleeding during laser surgery or tissue manipulation. The TRIO™ handpiece can be used with any Electro-Surgical Unit (ESU) with output power of up to 750 peak to peak voltage (Vp-p) and footswitch actuation. The instrument is provided with a 12-foot bipolar cable with fixed leads. The TRIO™ handpiece instrument can be used with any hospital or office suction apparatus. Fluid aspiration is controlled via a suction control port on the handle of the instrument.

The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece, is indicated for use to enable the surgeon to perform incision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. This system is intended for use with a grasper in the following medical special laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, urologic surgical procedures, otorhinolaryngology surgical procedures.

The OmniGuide Laser System with FlexGuide™ Ultra, which includes the FELS 25A Laser, BeamPath Fibers and the FlexGuide™ Ultra handpiece are used together to perform the intended use above. The FELS 25A Laser and BeamPath Fibers remain unchanged. Additionally, the BeamPath fibers that deliver the laser energy, are cleared for laparoscopic use. The BeamPath Fiber Optic Handpiece (K081939) has been modified to the FlexGuide™ Ultra handpiece, which includes a sterilization tray and are sold as non-sterile reusable devices. The FlexGuide Ultra is a flexible handpiece that consists of three main sections: the proximal rear sealing cap, handpiece body/cannula and distal tip. The material of the FlexGuide Ultra handpiece is stainless steel. The OmniGuide BeamPath fiber (K070157, K093451) is inserted through the flexible handpiece proximal rear sealing cap and is fixated so that it is visualized through two site holes at the handpiece distal tip. The OmniGuide FELS 25A Laser System (K093251) still generates the CO2 laser energy, which is transmitted through the fiber. During the procedure the surgeon grasps and holds the distal tip of the FlexGuide Ultra with a grasper. The FlexGuide Ultra distal tip may be used in either non-contact mode or contact mode. The surgeon may also use the distal tip to enable tissue manipulation.

The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

The OmniGuide OmniGuide BeamPath CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile/Low Loss metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter.

The OmniGuide BeamPath FELS 25A, CO2 Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues in the following specialties: - . Dermatology - General Surgery . - Gynecology . - Head & Neck Surgery . - Neurosurgery . - Oral Surgery ● - Orthopedic Surgery . - Otorhinolaryngology . - Pediatric Surgery ● - Plastic & Reconstructive Surgery - Podiatry . - · Urology The OmniGuide BeamPath® FELS 25A, CO2 Laser System intended to be used in conjunction with the OmniGuide BeamPath Adapter and the OmniGuide BeamPath fiber and is intended to be used for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues.

The OmniGuide BeamPath FELS 25A, CO2 Laser System, is a Carbon dioxide (CO2) Laser emitting light at a wavelength of 10.6 um. It has an RF excited laser tube which produces a maximum continuous wave (CW) output power of up to 30 watts. Laser energy (CO2), with a wavelength of 10.6 um, has a variety of attractive features for surgical use. Because it is strongly absorbed by water (the main constituent of biological tissue) it does not penetrate into tissue beyond the point of application of the laser energy. This small depth of penetration (0.1-0.2 mm) leads to high cutting precision and minimal thermal damage to adjacent tissue. In addition, the CO2 wavelength has excellent coagulation capabilities. The laser console is a table top console which can be easily transported from one surgery room to the other. The controls for the physician are part of the console and the parameters are clearly displayed on a large screen display. The laser light is guided through different mirrors and focused via an attached adapter is the interface allowing an OmniGuide BeamPath Fiber or equivalent to attach to the laser. Materials used are mainly machined aluminum or stainless Steel and standard optics for the transmission or the reflection of the CO2 laser wave length. Only the laser energy from the OmniGuide BeamPath FELS 25A, CO2 Laser System comes in contact with the patient. The energy is guided through a hollow waveguide such as the OmniGuide BeamPath hollow waveguide liber. It is worth noting that all components (mirrors, lenses and the fiber) that the CO2 light travels though are passive and do not alter the wayelength or any other of the fundamental properties or beneficial attributes of the CO2 Laser.

The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers to enable the surgeon to perform incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology.

The OmniGuide BeamPath® Fiber Optic HandPiece System and Sterilization Tray is indicated for use in conjunction with OmniGuide's waveguide fibers. The objectives of the hand-piece are to enable precision control and to stabilize surgeon hand motion. The waveguide fiber is inserted through the proximal end of the hand-piece and fixated so that it is observed at the hand-piece's distal tip. The surgeon wields the hand-piece as a pencil, and advances the hand-piece so that its distal tip is in close proximity to the target tissue to exert the desired effect of the waveguide fiber: incision. excision, ablation, vaporization and coagulation. The surgeon may use the hand-piece distal tip in either non-contact mode or contact mode, and may use the distal tip to enable tissue manipulation. The sterilization tray is purchased from SYMMETRY MEDICAL USA INC. and sold as a storage and sterilization tray for use with the OmniGuide Fiber Optic Handpieces, The handpieces consist of a handle and sealing cap consisting of either SS or aluminum, a silicone rubber fiber gripper and a lumen to guide the fiber made of SS hypodermic tubing. The handle/lumen are welded or adhesive bonded to for the unit. Lumen may be bent or straight to facilitate the aiming of the fiber. The tip is may be beveled or straight to improve the fiber visibility, fiber tip protection and blunt dissection.

The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy. gastroscopy. colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

The OmniGuide OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with Low Profile Tip is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. OmniGuide Beam Path CO2 Mark III WaveGuide Fiber with low profile metal tip is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter. The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy and a stainless steel waveguide distal tip. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um. The fiber has 14 mm long stainless steel tip that is used as a continuation of the waveguide, which enhances visualization in tight areas.

The OmniGuide Sterile WaveGuide Adapter System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

The OmniGuide Sterile WaveGuide Adapter System connects a hospitals CO2 laser to the OmniGuide WaveGuide Fibers. The additional filter and autoclave sterilization of the adapter and hose allows for use in sterile surgical procedures. The output tube and gas hose will be sold non-sterile and the hospital will autoclave sterilize. The filter element may be provided as a gamma sterilized device (high Pressure option) or as a non sterile device for autoclave sterilization. The low pressure filter may be autoclave sterilized or provided sterile at the end users request.

The OmniGuide Mark III WaveGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber is an accessory for CO2 laser systems. It consists of a flexible fiber assembly that delivers CO2 laser energy that enables minimally invasive surgery. The OmniGuide Beam Path CO2 Mark III WaveGuide Fiber is supplied sterile and is intended for single procedure use in conjunction with the OmniGuide Laser Adapter. The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.

The OmniGuide Zero Flow ZF-T WaveGuide Fiber is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy. The indications for use for which the delivery system is used for are dependent upon the cleared indications for use of the laser system and those laser system accessories to which it is attached.

The OmniGuide Zero Flow ZF-T WaveGuide fiber is an accessory for CO2 laser systems. It consists of a fiber assembly that propagates CO2 laser beams and vents the cooling gases outside of the body. The OmniGuide ZF-T wave guide fiber is supplied sterile and is intended for single procedure use. The device consists of an optical fiber assembly. The main functional component of the fiber assembly is a photonic bandgap reflector lining its hollow core that reflects and thereby guides CO2 laser energy. The fiber incorporates a lens at the tip which is transparent to the laser beam. The fiber also incorporates a sensor on the fiber tip that allows physicians to determine when the lens becomes obstructed by debris. The fiber assembly is 1 to 2 m long and transmits at the CO2 laser emission wavelength of 10.6 um.