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510(k) Data Aggregation
K Number
K162334Device Name
U.S. Laser Worx Patriot 1 family of lasers
Manufacturer
Date Cleared
2017-04-27
(248 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
U.S. Laser Worx
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
General Description- Thulium Laser/ Patriot 1 family of lasers. The U. S. Laser Worx Family of lasers are surgical instrument for use in general and plastic surgery and in dermatology (GEX). The Patriot 1 Family of lasers are installed with a single Tm:Fiber Laser Source with CW emission at 1.94 microns with adjustable power from 5 W to the maximum output power (as given below). The laser radiation is delivered to the tissue to be treated through fiber optics. The Patriot 1 Family (that includes 120, 150, 180 and the 200) and its accessories are intended for use in surqical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coaqulation and hemostasis of soft tissue in use in medical specialties including: Urology, Gastroenterology, Thoracic and Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery, General Surgery and Arthroscopy.
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