Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm)
K-Number: K221712 · 2022-10-12
Device Summary
Frequently Asked Questions
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.
Other records listing Fotona D.O.O. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: GEX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.