FDA 510(k)

HyPHo Laser System

N.º K: K163449 · 2017-06-23

Fecha de decisión2017-06-23

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

HyPHo Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Hyper Photonics Srl. It received FDA 510(k) clearance on 2017-06-23 under 510(k) number K163449. 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.

Preguntas frecuentes

What is the HyPHo Laser System?

HyPHo Laser System is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Hyper Photonics Srl. The 510(k) number is K163449.

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

HyPHo Laser System received FDA 510(k) clearance on 2017-06-23, under 510(k) number K163449.

Who is the listed applicant for HyPHo Laser System?

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

What is the FDA product code for HyPHo Laser System?

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

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Fuente oficial

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