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The Tracker / September 2026 / K254199

510(k) cleared

PicoreMax (PicoreMax)

BLUECORE COMPANY Co., Ltd. · Sep 24, 2026 · K254199

FDA cleared the PicoreMax (PicoreMax) from BLUECORE COMPANY Co., Ltd. on Sep 24, 2026 under K254199, 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 Dec 29, 2025. The decision came 269 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 BLUECORE COMPANY Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254199?

K254199 is the FDA 510(k) for PicoreMax (PicoreMax), submitted by BLUECORE COMPANY Co., Ltd.. FDA's decision date was Sep 24, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the PicoreMax (PicoreMax)?

BLUECORE COMPANY Co., Ltd., based in Yangsan, is the applicant of record for K254199.

How long did the K254199 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Sep 24, 2026, 269 days later.

← All decisions in September 2026