WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / August 2026 / K251544

510(k) cleared

Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

Lakong Medical Devices Co., Ltd. · Aug 7, 2026 · K251544

FDA cleared the Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) from Lakong Medical Devices Co., Ltd. on Aug 7, 2026 under K251544, a traditional 510(k). The device falls under product code EIA, Unit, Operative Dental, regulated at 21 CFR 872.6640 as a Class 1 device. The review panel was Dental.

FDA logged the submission as received on May 20, 2025. The decision came 444 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 Lakong Medical Devices Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251544?

K251544 is the FDA 510(k) for Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0), submitted by Lakong Medical Devices Co., Ltd.. FDA's decision date was Aug 7, 2026, under product code EIA (Unit, Operative Dental).

Who makes the Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)?

Lakong Medical Devices Co., Ltd., based in Dongguan, is the applicant of record for K251544.

How long did the K251544 review take?

FDA received the submission on May 20, 2025 and issued its decision on Aug 7, 2026, 444 days later.

← All decisions in August 2026