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FDA 510(k)

neoLaser Laser Surgery Fibers

K-Number: K250113 · 2025-03-13

ApplicantG.N.S Neolaser , Ltd.
Decision Date2025-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

neoLaser Laser Surgery Fibers is a medical device manufactured by G.N.S Neolaser , Ltd.. It received FDA 510(k) clearance on 2025-03-13 under approval 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.

Frequently Asked Questions

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. It is manufactured by G.N.S Neolaser , Ltd.. The 510(k) number is K250113.

When was neoLaser Laser Surgery Fibers approved by the FDA?

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

What company makes neoLaser Laser Surgery Fibers?

neoLaser Laser Surgery Fibers is manufactured by G.N.S Neolaser , Ltd..

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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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.

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