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FDA 510(k)

Laser Peripherals, LLC Family of Bare Laser Fibers

K-Number: K170366 · 2017-06-08

ApplicantLaser Peripherals, LLC
Decision Date2017-06-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Laser Peripherals, LLC Family of Bare Laser Fibers is a medical device manufactured by Laser Peripherals, LLC. It received FDA 510(k) clearance on 2017-06-08 under approval number K170366. 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 Laser Peripherals, LLC Family of Bare Laser Fibers?

Laser Peripherals, LLC Family of Bare Laser Fibers is a medical device that received FDA 510(k) clearance on 2017-06-08. It is manufactured by Laser Peripherals, LLC. The 510(k) number is K170366.

When was Laser Peripherals, LLC Family of Bare Laser Fibers approved by the FDA?

Laser Peripherals, LLC Family of Bare Laser Fibers received FDA 510(k) clearance on 2017-06-08, under approval number K170366.

What company makes Laser Peripherals, LLC Family of Bare Laser Fibers?

Laser Peripherals, LLC Family of Bare Laser Fibers is manufactured by Laser Peripherals, LLC.

What is the FDA product code for Laser Peripherals, LLC Family of Bare Laser Fibers?

The FDA product code for Laser Peripherals, LLC Family of Bare Laser Fibers 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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