FDA 510(k)

EpiLaze Multi-wavelength Laser

Número K: K191162 · 2019-07-09

Data da decisão2019-07-09

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EpiLaze Multi-wavelength Laser is the device name listed in this FDA 510(k) record. The listed applicant is Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2019-07-09 under 510(k) number K191162. 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 EpiLaze Multi-wavelength Laser?

EpiLaze Multi-wavelength Laser is a medical device that received FDA 510(k) clearance on 2019-07-09. The listed applicant is Rohrer Aesthetics, LLC. The 510(k) number is K191162.

When did EpiLaze Multi-wavelength Laser receive FDA 510(k) clearance?

EpiLaze Multi-wavelength Laser received FDA 510(k) clearance on 2019-07-09, under 510(k) number K191162.

Who is the listed applicant for EpiLaze Multi-wavelength Laser?

The FDA 510(k) record lists Rohrer Aesthetics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EpiLaze Multi-wavelength Laser?

The FDA product code for EpiLaze Multi-wavelength Laser is GEX. This falls under the Gastroenterology category.

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