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FDA 510(k)

U.S. Laser Worx Patriot 1 family of lasers

K-Number: K162334 · 2017-04-27

ApplicantU.S. Laser Worx
Decision Date2017-04-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

U.S. Laser Worx Patriot 1 family of lasers is a medical device manufactured by U.S. Laser Worx. It received FDA 510(k) clearance on 2017-04-27 under approval 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. It is manufactured by U.S. Laser Worx. The 510(k) number is K162334.

When was U.S. Laser Worx Patriot 1 family of lasers approved by the FDA?

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

What company makes U.S. Laser Worx Patriot 1 family of lasers?

U.S. Laser Worx Patriot 1 family of lasers is manufactured by U.S. Laser Worx.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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