FDA 510(k)

CO2 Laser Therapy System

Número K: K192528 · 2019-12-03

RequerenteShangdong Huamei Technology Co., Ltd.

Data da decisão2019-12-03

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CO2 Laser Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-12-03 under 510(k) number K192528. 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 CO2 Laser Therapy System?

CO2 Laser Therapy System is a medical device that received FDA 510(k) clearance on 2019-12-03. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K192528.

When did CO2 Laser Therapy System receive FDA 510(k) clearance?

CO2 Laser Therapy System received FDA 510(k) clearance on 2019-12-03, under 510(k) number K192528.

Who is the listed applicant for CO2 Laser Therapy System?

The FDA 510(k) record lists Shangdong Huamei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Therapy System?

The FDA product code for CO2 Laser Therapy System is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Shangdong Huamei Technology Co., Ltd. como candidato(a)

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