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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 / K253461

510(k) cleared

Demi Pro

Meta Systems Co., Ltd. · Oct 14, 2025 · K253461

FDA cleared the Demi Pro from Meta Systems Co., Ltd. on Oct 14, 2025 under K253461, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code EBZ, Activator, Ultraviolet, For Polymerization, regulated at 21 CFR 872.6070 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Oct 7, 2025. The decision came 7 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Meta Systems Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253461?

K253461 is the FDA 510(k) for Demi Pro, submitted by Meta Systems Co., Ltd.. FDA's decision date was Oct 14, 2025, under product code EBZ (Activator, Ultraviolet, For Polymerization).

Who makes the Demi Pro?

Meta Systems Co., Ltd., based in Seongnam-Si, is the applicant of record for K253461.

How long did the K253461 review take?

FDA received the submission on Oct 7, 2025 and issued its decision on Oct 14, 2025, 7 days later.

← All decisions in October 2025