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The InnoVoyce VYLO is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include: General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries. Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids). Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids. Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis. Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type. Ophthalmology: Post-vitrectomy endophotocoagulation of the retina. Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures. Spinal Surgery: Percutaneous lumbar diskectomy. Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures. Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia (BPH).

InnoVoyce VYLO is a solid-state laser device with laser energy generated by internal diodes. The laser output energy of the device is in the blue spectrum at wavelength of 445-465nm. The system is intended to be used by professional practitioners (specialized physician/ authorized technical personnel) in the medical field. The system is intended for use in professional healthcare facility environments. The VYLO's base unit is a console with a graphical touch screen user interface and a footswitch, and single-use, disposable LOFs. The system has four laser emission modes: Continuous Wave (CW), Pulsed Wave (PW), Quasi Pulsed Wave (QPW), and Quasi Continuous Wave (QCW).

InnoVoyce Laser Fiber is intended for use in incision, vaporization, ablation, and coagulation of soft tissue.

The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser. They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers. The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer.