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FDA 510(k)

Laser Peripherals, LLC Family of Bare Laser Fibers

Número K: K170366 · 2017-06-08

RequerenteLaser Peripherals, LLC
Data da decisão2017-06-08
Código do produtoGEX
Comité consultivoSU
DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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