510(k) · Cleared

Cleared

U.S. Laser Worx Patriot 1 family of lasers

K162334510(k) TraditionalCleared Apr 27, 2017248-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

U.S. Laser Worx · GEX Powered Laser Surgical Instrument

Cleared on Apr 27, 2017 as substantially equivalent to K070476 (Allmed Systems, Inc., 2007) and 1 other predicate after a 248-day review. Its family tree reaches back 4 generations to 2006. 1 later device descends from it.

Decided: Apr 27, 2017
Review: 248 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K062719 (2006). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK062719 Greenlight HPS Series Surgical Laser System & AccessoriesLaserscope · 2006 · Recalled
3 generations backK090962 Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber…Quanta System Spa · 2009
2 generations backK102749 Quanta Cyber TM 150WQuanta System Spa · 2010
1 generation backK131081 Cyber TM FamilyQuanta System Spa · 2013
This deviceK162334 U.S. Laser Worx Patriot 1 family of lasersU.S. Laser Worx · 2017
Descendant · cites it directly · 0 of its ownK251824 Patriot DuoPatriot Laser, LLC · 2025

Most influential descendants

Showing 1 of 1 · See all

K251824Patriot DuoPatriot Laser, LLC · 2025 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K062719	Greenlight HPS Series Surgical Laser System & Accessories	Laserscope	2006	5
−3	K090962	Cyber Surgical Laser Family Including: Cyber TM, Cyber Green, Cyber Green TM	Quanta System Spa	2009	—
−2	K102749	Quanta Cyber TM 150W	Quanta System Spa	2010	—
−1	K131081	Cyber TM Family	Quanta System Spa	2013	—
0 (this device)	K162334	U.S. Laser Worx Patriot 1 family of lasers	U.S. Laser Worx	2017	—
+1	K251824	Patriot Duo	Patriot Laser, LLC	2025	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2013	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2025	1	0

FIG. 1 — Lineage of K162334, 2006–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K070476	Revolix 120 Summary page 18 …120 Cyber Tm 120, 150, Lasers 180 and 200 Concurrence: Pending K070476 K131081 510(k) Number: Laser Medium: Tm:Fiber Tm:Fiber Tm:Fiber Wa…	Allmed Systems, Inc.	2007	—
*	K131081	Cyber TM Family Summary page 9 …ogy Predicate Devices: AllMed Systems, Inc. Revolix 120 (K07046) and the Quanta System Cyber Tm 120, Tm 150, Tm 180 and the Tm 200 (K131081) Review Panel: General and Plastic Surgery (GEX) PRODUCT CODE: GEX Device Description: General Descripti…	Quanta System Spa	2013	—

Also cleared against K070476: 3 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K251824	Patriot Duo	Patriot Laser, LLC	2025	0

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 11 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
1 of the 6 ancestors has a recall of any class.
Of its descendants, K251824 (Patriot Laser, LLC, 2025) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K070476.

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. 2017, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

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

Recalls per year · GEX

3in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

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. Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and…

Read the full statement (465 words)

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.

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

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

Note: The Patriot 1 180 and 200 are only cleared for BPH when using over 150 W

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K162334 · printed Nov 6, 2026

Cite this page

510(k) Report. “K162334: U.S. Laser Worx Patriot 1 family of lasers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162334

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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

U.S. Laser Worx Patriot 1 family of lasers

Line of descent and top descendants

Other ancestors by year cleared

Descendants by year cleared

What was it cleared against? (2)

What descends from it? (1)

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

What does this lineage say?

How does its category compare?

What is it indicated for?

Also cleared against K070476

Recent decisions in GEX