FDA 510(k)

neoLaser Laser Surgery Fibers

Numéro K : K250113 · 2025-03-13

Date de décision2025-03-13

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

neoLaser Laser Surgery Fibers is the device name listed in this FDA 510(k) record. The listed applicant is G.N.S Neolaser , Ltd.. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K250113. 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.

Questions fréquentes

What is the neoLaser Laser Surgery Fibers?

neoLaser Laser Surgery Fibers is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is G.N.S Neolaser , Ltd.. The 510(k) number is K250113.

When did neoLaser Laser Surgery Fibers receive FDA 510(k) clearance?

neoLaser Laser Surgery Fibers received FDA 510(k) clearance on 2025-03-13, under 510(k) number K250113.

Who is the listed applicant for neoLaser Laser Surgery Fibers?

The FDA 510(k) record lists G.N.S Neolaser , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for neoLaser Laser Surgery Fibers?

The FDA product code for neoLaser Laser Surgery Fibers is GEX. This falls under the Gastroenterology category.

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Source officielle

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