Patriot Duo

The Patriot Duo in the CW mode is intended for Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissues including:

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures, Bladder Neck Incisions (BNI), Ablation and resection of Bladder Tumors, Urethral Tumors and Ureteral Tumors, Ablation of Benign Prostatic Hypertrophy (BPH), Transurethral incision of the prostate (TUIP), Laser Resection of the Prostate (HoLRP), Laser Enucleation of the Prostate (HoLEP), Laser Ablation of the Prostate (HoLAP), Condylomas and Lesions of external genitalia.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Rendu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions.

Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue including: Laryngeal Lesions, Airway obstructions including carcinoma, Polyps and Granulomas, Palliation of obstructing carcinomas of the tracheobronchial tree.

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis), Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and/or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix.

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal, Tonsillectomy, Adenoidectomy.

Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas, Lesions of skin and subcutaneous tissue, Skin tags, Plantar warts.

General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy, Biopsy, Skin incisio

The Patriot Duo in the CW mode is intended for Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and hemostasis) of soft tissues including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology and Plastic Surgery, and General Surgery.

The Patriot Duo Laser, fibers and related accessories are substantially equivalent to the predicate devices, The U.S. Laser Worx Patriot 1 Family of Lasers, fibers and associated accessories (K162334) and the Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser, Laser fibers and accessories (K183647). The Patriot Duo is essentially the exact same device in the CW mode of operation as the Patriot 1 Family of Lasers. The Patriot Duo also employs a Quasi CW (SuperPulse) module allowing the Patriot Duo to operate in both the CW and Quasi CW (SuperPulse) modes to expand the Indications for Use (IFU's) to include Laser Lithotripsy and a variety of other clinical indications in the Quasi CW (SuperPulse) mode. In the Patriot Duo each mode of operation is completely independent and may not be used at the same time or simultaneously, hence Patriot Laser LLC is simply requesting FDA Premarket Approval of two previously cleared modalities to be available in one system.