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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 / K251824

510(k) cleared

Patriot Duo

Patriot Laser, LLC · Oct 27, 2025 · K251824

FDA cleared the Patriot Duo from Patriot Laser, LLC on Oct 27, 2025 under K251824, 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 Jun 13, 2025. The decision came 136 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 Patriot Laser, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251824?

K251824 is the FDA 510(k) for Patriot Duo, submitted by Patriot Laser, LLC. FDA's decision date was Oct 27, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Patriot Duo?

Patriot Laser, LLC, based in Phoenix, AZ, is the applicant of record for K251824.

How long did the K251824 review take?

FDA received the submission on Jun 13, 2025 and issued its decision on Oct 27, 2025, 136 days later.

← All decisions in October 2025