FDA 510(k)

RevoLix HTL

Número K: K211534 · 2022-05-19

Data da decisão2022-05-19

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RevoLix HTL is the device name listed in this FDA 510(k) record. The listed applicant is Lisa Laser Products GmbH. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K211534. 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 RevoLix HTL?

RevoLix HTL is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Lisa Laser Products GmbH. The 510(k) number is K211534.

When did RevoLix HTL receive FDA 510(k) clearance?

RevoLix HTL received FDA 510(k) clearance on 2022-05-19, under 510(k) number K211534.

Who is the listed applicant for RevoLix HTL?

The FDA 510(k) record lists Lisa Laser Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RevoLix HTL?

The FDA product code for RevoLix HTL is GEX. This falls under the Gastroenterology category.

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