FDA 510(k)

ERISE Laser handpiece

Número K: K202258 · 2021-04-26

RequerenteEl.En Electronic Engineering Spa

Data da decisão2021-04-26

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

ERISE Laser handpiece is the device name listed in this FDA 510(k) record. The listed applicant is El.En Electronic Engineering Spa. It received FDA 510(k) clearance on 2021-04-26 under 510(k) number K202258. 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 ERISE Laser handpiece?

ERISE Laser handpiece is a medical device that received FDA 510(k) clearance on 2021-04-26. The listed applicant is El.En Electronic Engineering Spa. The 510(k) number is K202258.

When did ERISE Laser handpiece receive FDA 510(k) clearance?

ERISE Laser handpiece received FDA 510(k) clearance on 2021-04-26, under 510(k) number K202258.

Who is the listed applicant for ERISE Laser handpiece?

The FDA 510(k) record lists El.En Electronic Engineering Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ERISE Laser handpiece?

The FDA product code for ERISE Laser handpiece is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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