FDA 510(k)

Syneron CO2RE System

Número K: K181523 · 2018-07-11

Data da decisão2018-07-11

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Syneron CO2RE System is the device name listed in this FDA 510(k) record. The listed applicant is Syneron-Candela Corp. It received FDA 510(k) clearance on 2018-07-11 under 510(k) number K181523. 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 Syneron CO2RE System?

Syneron CO2RE System is a medical device that received FDA 510(k) clearance on 2018-07-11. The listed applicant is Syneron-Candela Corp. The 510(k) number is K181523.

When did Syneron CO2RE System receive FDA 510(k) clearance?

Syneron CO2RE System received FDA 510(k) clearance on 2018-07-11, under 510(k) number K181523.

Who is the listed applicant for Syneron CO2RE System?

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

What is the FDA product code for Syneron CO2RE System?

The FDA product code for Syneron CO2RE System is GEX. This falls under the Gastroenterology category.

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