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The Tracker / October 2026 / K261572

510(k) cleared

Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)

Keyue (Hangzhou) Medical Information Technology Co., Ltd. · Oct 13, 2026 · K261572

FDA cleared the Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo) from Keyue (Hangzhou) Medical Information Technology Co., Ltd. on Oct 13, 2026 under K261572, 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 May 12, 2026. The decision came 154 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 Keyue (Hangzhou) Medical Information Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261572?

K261572 is the FDA 510(k) for Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo), submitted by Keyue (Hangzhou) Medical Information Technology Co., Ltd.. FDA's decision date was Oct 13, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)?

Keyue (Hangzhou) Medical Information Technology Co., Ltd., based in Hangzhou, is the applicant of record for K261572.

How long did the K261572 review take?

FDA received the submission on May 12, 2026 and issued its decision on Oct 13, 2026, 154 days later.

← All decisions in October 2026