510(k) Report

510(k) · Cleared

Cleared

Patriot Duo

K251824510(k) TraditionalCleared Oct 27, 2025136-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Patriot Laser, LLC · GEX Powered Laser Surgical Instrument

Cleared on Oct 27, 2025 as substantially equivalent to K162334 (U.S. Laser Worx, 2017) and 1 other predicate after a 136-day review. Its family tree reaches back 9 generations to 1994.

Decided
Oct 27, 2025
Review
136 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
2

Its longest line of descent runs back 9 generations to K936109 (1994). 41 ancestors in all, the oldest K853620 (1986). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2017: 1 other ancestor2013: 2 other ancestors2011: 1 other ancestor2007: 1 other ancestor2010: 1 other ancestor2009: 1 other ancestor2006: 1 other ancestor2000: 1 other ancestor1999: 1 other ancestor1995: 4 other ancestors1998: 3 other ancestors1996: 2 other ancestors1994: 3 other ancestors1993: 1 other ancestor1992: 2 other ancestors1991: 3 other ancestors1990: 1 other ancestor1989: 1 other ancestor1997: 1 other ancestor1986: 1 other ancestorK936109 · Sharplan Model 1120 CO2 Surgical Laser · Sharplan Lasers, Inc. · 1994K960521 · Sharplan Lasers, Inc. Silktouch Flash Scanner · Sharplan Lasers, Inc. · 1996K963339 · Coherent Ultrapulse CO2 Surgical Lasers · Coherent Medical Group · 1997K974789 · Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L · Lumenis, Inc. · 1998K990947 · Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO: Yag/ND: Yag Surgical Lasers and Delivery · Lumenis, Inc. · 1999K011703 · Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength (HO:Yag/ND:Yag) Surgical Lasers and Delivery Devices · Lumenis · 2001 · recalledK140388 · Lumenis Pulse 120H · Lumenis, Ltd. · 2014K170121 · Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories · Lumenis, Ltd. · 2017 · recalledK183647 · SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) · Olympus Surgical Technologies America · 2019 · recalled1990200020102020
  1. Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
  2. 5 generations between
  3. 3 generations backK140388 Lumenis Pulse 120HLumenis, Ltd. · 2014
  4. 2 generations backK170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and…Lumenis, Ltd. · 2017 · Recalled
  5. 1 generation backK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
  6. This deviceK251824 Patriot DuoPatriot Laser, LLC · 2025
Show all 9 generations
  1. Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
  2. 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
  3. 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
  4. 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
  5. 5 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
  6. 4 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
  7. 3 generations backK140388 Lumenis Pulse 120HLumenis, Ltd. · 2014
  8. 2 generations backK170121 Lumenis Family of Holmium Surgical Lasers and Delivery Devices and…Lumenis, Ltd. · 2017 · Recalled
  9. 1 generation backK183647 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™…Olympus Surgical Technologies America · 2019 · Recalled
  10. This deviceK251824 Patriot DuoPatriot Laser, LLC · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K936109Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc.1994—
−8K960521Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc.1996—
−7K963339Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group1997—
−6K974789Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc.1998—
−5K990947Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO…Lumenis, Inc.1999—
−4K011703Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis20012
−3K140388Lumenis Pulse 120HLumenis, Ltd.2014—
−2K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesLumenis, Ltd.20171
−1K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium…Olympus Surgical Technologies America20194
0 (this device)K251824Patriot DuoPatriot Laser, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198910
199010
199130
199220
199310
199430
199540
199620
199710
199830
199910
200010
200610
200710
200910
201010
201110
201320
201710
FIG. 1 — Lineage of K251824, 1994–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K162334U.S. Laser Worx Patriot 1 family of lasers
Summary page 7
…general and plastic surgery and in dermatology. Product Code GEX (Class 2) – Powered Laser Surgical Instrument Predicate Devices K162334, Patriot 1 K183647, SOLTIVE™ Premium Page 1 of 16 === Pa…
U.S. Laser Worx2017—
*K183647SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed…
Summary page 7
…and in dermatology. Product Code GEX (Class 2) – Powered Laser Surgical Instrument Predicate Devices K162334, Patriot 1 K183647, SOLTIVE™ Premium Page 1 of 16 Patriot Duo 510k Summary…
Olympus Surgical Technologies America20194

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
  • 4 of the 41 ancestors have a recall of any class.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

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…

Read the full statement (635 words)

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

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K251824: Patriot Duo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251824

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026