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The Tracker / September 2026 / K254185

510(k) cleared

Potenza Prime

Jeisys Medical Incorporated · Sep 11, 2026 · K254185

FDA cleared the Potenza Prime from Jeisys Medical Incorporated on Sep 11, 2026 under K254185, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 23, 2025. The decision came 262 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 Jeisys Medical Incorporated in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254185?

K254185 is the FDA 510(k) for Potenza Prime, submitted by Jeisys Medical Incorporated. FDA's decision date was Sep 11, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Potenza Prime?

Jeisys Medical Incorporated, based in Seoul, is the applicant of record for K254185.

How long did the K254185 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Sep 11, 2026, 262 days later.

← All decisions in September 2026