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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 / October 2025 / K250731

510(k) cleared

MateLaser Medical Diode Laser Systems (ML-DLS-30)

Matelaser, Inc. · Oct 16, 2025 · K250731

FDA cleared the MateLaser Medical Diode Laser Systems (ML-DLS-30) from Matelaser, Inc. on Oct 16, 2025 under K250731, a traditional 510(k). The device falls under product code NVK, Laser, Dental, Soft Tissue, 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 Mar 11, 2025. The decision came 219 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 Matelaser, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250731?

K250731 is the FDA 510(k) for MateLaser Medical Diode Laser Systems (ML-DLS-30), submitted by Matelaser, Inc.. FDA's decision date was Oct 16, 2025, under product code NVK (Laser, Dental, Soft Tissue).

Who makes the MateLaser Medical Diode Laser Systems (ML-DLS-30)?

Matelaser, Inc., based in Miami, FL, is the applicant of record for K250731.

How long did the K250731 review take?

FDA received the submission on Mar 11, 2025 and issued its decision on Oct 16, 2025, 219 days later.

← All decisions in October 2025