FDA 510(k)

Vbeam Prima Laser System

Número K: K183452 · 2019-02-01

Data da decisão2019-02-01

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Vbeam Prima Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Candela Corp.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K183452. 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 Vbeam Prima Laser System?

Vbeam Prima Laser System is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Candela Corp.. The 510(k) number is K183452.

When did Vbeam Prima Laser System receive FDA 510(k) clearance?

Vbeam Prima Laser System received FDA 510(k) clearance on 2019-02-01, under 510(k) number K183452.

Who is the listed applicant for Vbeam Prima Laser System?

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

What is the FDA product code for Vbeam Prima Laser System?

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

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