FDA 510(k)

LightForce LTS Model 1000, 1500, 2500, and 4000

Número K: K173067 · 2018-02-22

Data da decisão2018-02-22

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LightForce LTS Model 1000, 1500, 2500, and 4000 is the device name listed in this FDA 510(k) record. The listed applicant is Litecure, LLC. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K173067. 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 LightForce LTS Model 1000, 1500, 2500, and 4000?

LightForce LTS Model 1000, 1500, 2500, and 4000 is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Litecure, LLC. The 510(k) number is K173067.

When did LightForce LTS Model 1000, 1500, 2500, and 4000 receive FDA 510(k) clearance?

LightForce LTS Model 1000, 1500, 2500, and 4000 received FDA 510(k) clearance on 2018-02-22, under 510(k) number K173067.

Who is the listed applicant for LightForce LTS Model 1000, 1500, 2500, and 4000?

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

What is the FDA product code for LightForce LTS Model 1000, 1500, 2500, and 4000?

The FDA product code for LightForce LTS Model 1000, 1500, 2500, and 4000 is GEX. This falls under the Gastroenterology category.

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