Manufacturer
U.S. Laser WorxU.S. Laser Worx Patriot 1 family of lasers
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K162334
- Device name
- U.S. Laser Worx Patriot 1 family of lasers
- Company
- U.S. Laser Worx
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-08-22
- Decision date
- 2017-04-27
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Patriot 1 Family of Lasers, 400, 600 and 1000 micron sterile, disposable, single use fibers are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery, and general surgery. 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-Renu 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 incision - Tissue dissection - Excision of external tumors and lesions - Complete or partial resection of internal organs, tumors and lesions - Mastectomy - Hepatectomy - Pancreatectomy - Splenectomy - Thyroidectomy - Parathyroidectomy - Herniorrhaphy - Tonsillectomy - Lymphadenectomy - Partial Nephrectomy - Pilonidal Cystectomy -
Intended Use
The Patriot 1 Family of Lasers, 400, 600 and 1000 micron sterile, disposable, single use fibers are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered in urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.
Device Description
The Patriot 1 Family of Lasers is a Thulium Laser system that includes 400, 600 and 1000 micron sterile, disposable, single use fibers.
Summary parsed at:2026-06-01 05:58:48 UTC
Predicate devices
2Cited as predicate
1Patriot Duo
1 submission cite K162334 as a predicate
