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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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.

Lakong Medical Devices Co., Ltd. has one other decision in the tracker over the last 12 months: K254009 (Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)).

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

Sources