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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / November 2025 / K251303

510(k) cleared

Tamburo Thulium Fiber Laser System

Menovex Medical Technology (Shenzhen) Co., Ltd. · Nov 4, 2025 · K251303

FDA cleared the Tamburo Thulium Fiber Laser System from Menovex Medical Technology (Shenzhen) Co., Ltd. on Nov 4, 2025 under K251303, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 28, 2025. The decision came 190 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Menovex Medical Technology (Shenzhen) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251303?

K251303 is the FDA 510(k) for Tamburo Thulium Fiber Laser System, submitted by Menovex Medical Technology (Shenzhen) Co., Ltd.. FDA's decision date was Nov 4, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Tamburo Thulium Fiber Laser System?

Menovex Medical Technology (Shenzhen) Co., Ltd., based in Shenzhen, is the applicant of record for K251303.

How long did the K251303 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Nov 4, 2025, 190 days later.

← All decisions in November 2025