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The Tracker / September 2026 / K261047

510(k) cleared

Dental Diode Laser Device (Laser-Pen)

Guilin Kevin Peter Technology Co., Ltd. · Sep 18, 2026 · K261047

FDA cleared the Dental Diode Laser Device (Laser-Pen) from Guilin Kevin Peter Technology Co., Ltd. on Sep 18, 2026 under K261047, 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 Mar 31, 2026. The decision came 171 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Guilin Kevin Peter Technology Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261695 (Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)), K261514 (Calcium Hydroxide Temporary Filling Material (KP-Cal)), K261415 (Injectable Root Canal Sealer (KP-Root SP)).

Questions & Answers

What did FDA clear under K261047?

K261047 is the FDA 510(k) for Dental Diode Laser Device (Laser-Pen), submitted by Guilin Kevin Peter Technology Co., Ltd.. FDA's decision date was Sep 18, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Dental Diode Laser Device (Laser-Pen)?

Guilin Kevin Peter Technology Co., Ltd., based in Guilin, is the applicant of record for K261047.

How long did the K261047 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Sep 18, 2026, 171 days later.

← All decisions in September 2026

Sources