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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 the device name listed in this FDA 510(k) record. The listed applicant is Laser Peripherals, LLC. It received FDA 510(k) clearance on 2017-06-08 under 510(k) 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. The listed applicant is Laser Peripherals, LLC. The 510(k) number is K170366.

When did Laser Peripherals, LLC Family of Bare Laser Fibers receive FDA 510(k) clearance?

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

Who is the listed applicant for Laser Peripherals, LLC Family of Bare Laser Fibers?

The FDA 510(k) record lists Laser Peripherals, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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