FDA 510(k)

LaseMD LEO Laser System

Número K: K192331 · 2019-11-12

Data da decisão2019-11-12

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LaseMD LEO Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Global. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K192331. 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 LaseMD LEO Laser System?

LaseMD LEO Laser System is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is Lutronic Global. The 510(k) number is K192331.

When did LaseMD LEO Laser System receive FDA 510(k) clearance?

LaseMD LEO Laser System received FDA 510(k) clearance on 2019-11-12, under 510(k) number K192331.

Who is the listed applicant for LaseMD LEO Laser System?

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

What is the FDA product code for LaseMD LEO Laser System?

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

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