# K251824: Patriot Duo

- Pathway: 510(k) (Traditional)
- Applicant: Patriot Laser, LLC
- Decided: Oct 27, 2025 after 136 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K936109 (1994). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162334: U.S. Laser Worx Patriot 1 family of lasers, U.S. Laser Worx (2017) Summary page 7.
- K183647: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories), Olympus Surgical Technologies America (2019) Summary page 7.

## Indications for use
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, Uretheral Tumors and Ureteral Tumors, Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP), Laser Resection of the Prostrate (HoLRP), Laser Enuculeation 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, Pancreatitas, 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, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer, Biopsy Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue), Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and non vascular tissue, In minimally invasive spinal surgery The Patriot Duo in the Quasi-CW (SuperPulse) mode is intended for: Urology Ablation of Benign Prostatic Hypertrophy (BPH), Laser Resection of the Prostrate (LRP), Laser Enucleation of the Prostate (LEP), Laser Ablation of the Prostate (LAP), Transurethral Incision of the Prostate (TUIP), Condylomas, Urethral strictures, Lesions of external genitalia, Bladder neck incisions (BNI), Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors, Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi, Treatment of distal impacted fragments remaining in the ureters following lithotripsy. Lithotripsy and Percutaneous Urinary Lithotripsy Indications Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones. Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Haemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the OslerWeber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions Gynecology Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of the soft tissue. Note: The Patriot Duo for CW mode is only cleared for BPH when using over 150 W

Source page: https://510kreport.com/device/K251824
Methodology: https://510kreport.com/methodology