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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K254009

510(k) cleared

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

Lakong Medical Devices Co., Ltd. · Sep 10, 2026 · K254009

FDA cleared the Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) from Lakong Medical Devices Co., Ltd. on Sep 10, 2026 under K254009, a traditional 510(k). The review panel was Dental.

FDA logged the submission as received on Dec 15, 2025. The decision came 269 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: K251544 (Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)).

Questions & Answers

What did FDA clear under K254009?

K254009 is the FDA 510(k) for Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV), submitted by Lakong Medical Devices Co., Ltd.. FDA's decision date was Sep 10, 2026, under product code SJH.

Who makes the Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)?

Lakong Medical Devices Co., Ltd., based in Dongguan, is the applicant of record for K254009.

How long did the K254009 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Sep 10, 2026, 269 days later.

← All decisions in September 2026