FDA 510(k)

neoLaser Laser Surgery Fibers

K-Number: K250113 · 2025-03-13

Decision Date2025-03-13

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

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.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies America K261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.