FDA 510(k)

UltraClear Fractional Laser System

Número K: K210847 · 2021-12-10

Data da decisão2021-12-10

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

UltraClear Fractional Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Fa International, LP. It received FDA 510(k) clearance on 2021-12-10 under 510(k) number K210847. 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 UltraClear Fractional Laser System?

UltraClear Fractional Laser System is a medical device that received FDA 510(k) clearance on 2021-12-10. The listed applicant is Fa International, LP. The 510(k) number is K210847.

When did UltraClear Fractional Laser System receive FDA 510(k) clearance?

UltraClear Fractional Laser System received FDA 510(k) clearance on 2021-12-10, under 510(k) number K210847.

Who is the listed applicant for UltraClear Fractional Laser System?

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

What is the FDA product code for UltraClear Fractional Laser System?

The FDA product code for UltraClear Fractional Laser System is GEX. This falls under the Gastroenterology category.

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