FDA 510(k)

Lustre PRO Light System

Número K: K143713 · 2016-01-19

Data da decisão2016-01-19

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Lustre PRO Light System is the device name listed in this FDA 510(k) record. The listed applicant is Ambicare Health, Ltd.. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K143713. 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 Lustre PRO Light System?

Lustre PRO Light System is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Ambicare Health, Ltd.. The 510(k) number is K143713.

When did Lustre PRO Light System receive FDA 510(k) clearance?

Lustre PRO Light System received FDA 510(k) clearance on 2016-01-19, under 510(k) number K143713.

Who is the listed applicant for Lustre PRO Light System?

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

What is the FDA product code for Lustre PRO Light System?

The FDA product code for Lustre PRO Light System is GEX. This falls under the Gastroenterology category.

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