FDA 510(k)

U.S. Laser Worx Patriot 1 family of lasers

K-Number: K162334 · 2017-04-27

Decision Date2017-04-27

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

U.S. Laser Worx Patriot 1 family of lasers is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Laser Worx. It received FDA 510(k) clearance on 2017-04-27 under 510(k) number K162334. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U.S. Laser Worx Patriot 1 family of lasers?

U.S. Laser Worx Patriot 1 family of lasers is a medical device that received FDA 510(k) clearance on 2017-04-27. The listed applicant is U.S. Laser Worx. The 510(k) number is K162334.

When did U.S. Laser Worx Patriot 1 family of lasers receive FDA 510(k) clearance?

U.S. Laser Worx Patriot 1 family of lasers received FDA 510(k) clearance on 2017-04-27, under 510(k) number K162334.

Who is the listed applicant for U.S. Laser Worx Patriot 1 family of lasers?

The FDA 510(k) record lists U.S. Laser Worx as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for U.S. Laser Worx Patriot 1 family of lasers?

The FDA product code for U.S. Laser Worx Patriot 1 family of lasers is GEX. This falls under the Gastroenterology category.

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Official Source

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