FDA 510(k)

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)

N.º K: K221712 · 2022-10-12

Fecha de decisión2022-10-12

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2022-10-12 under 510(k) number K221712. 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 Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)?

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) is a medical device that received FDA 510(k) clearance on 2022-10-12. The listed applicant is Fotona D.O.O.. The 510(k) number is K221712.

When did Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) receive FDA 510(k) clearance?

Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) received FDA 510(k) clearance on 2022-10-12, under 510(k) number K221712.

Who is the listed applicant for Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)?

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

What is the FDA product code for Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)?

The FDA product code for Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) is GEX. This falls under the Gastroenterology category.

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Fuente oficial

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