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The Tracker / September 2026 / K252723

510(k) cleared

Dynamis Pro Family

Fotona D.O.O. · Sep 19, 2026 · K252723

FDA cleared the Dynamis Pro Family from Fotona D.O.O. on Sep 19, 2026 under K252723, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Aug 28, 2025. The decision came 387 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 Fotona D.O.O. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252723?

K252723 is the FDA 510(k) for Dynamis Pro Family, submitted by Fotona D.O.O.. FDA's decision date was Sep 19, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Dynamis Pro Family?

Fotona D.O.O., based in Ljubljana, is the applicant of record for K252723.

How long did the K252723 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Sep 19, 2026, 387 days later.

← All decisions in September 2026