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FDA 510(k)

Tamburo Thulium Fiber Laser System

K-Number: K251303 · 2025-11-04

ApplicantMenovex Medical Technology (Shenzhen) Co., Ltd.
Decision Date2025-11-04
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tamburo Thulium Fiber Laser System is a medical device manufactured by Menovex Medical Technology (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2025-11-04 under approval number K251303. 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 Tamburo Thulium Fiber Laser System?

Tamburo Thulium Fiber Laser System is a medical device that received FDA 510(k) clearance on 2025-11-04. It is manufactured by Menovex Medical Technology (Shenzhen) Co., Ltd.. The 510(k) number is K251303.

When was Tamburo Thulium Fiber Laser System approved by the FDA?

Tamburo Thulium Fiber Laser System received FDA 510(k) clearance on 2025-11-04, under approval number K251303.

What company makes Tamburo Thulium Fiber Laser System?

Tamburo Thulium Fiber Laser System is manufactured by Menovex Medical Technology (Shenzhen) Co., Ltd..

What is the FDA product code for Tamburo Thulium Fiber Laser System?

The FDA product code for Tamburo Thulium Fiber Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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