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The Tracker / September 2026 / K261673

510(k) cleared

LED Therapy Device (QLXY-01)

Beijing Nubway S&T Co., Ltd. · Sep 17, 2026 · K261673

FDA cleared the LED Therapy Device (QLXY-01) from Beijing Nubway S&T Co., Ltd. on Sep 17, 2026 under K261673, 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 21, 2026. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Beijing Nubway S&T Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261841 (Q Switched Nd:YAG Laser machine (QLQW-01)), K261693 (Diode laser hair removal machine (QDTM-04)), K261674 (Skin Air Cooling System (QALF-01)).

Questions & Answers

What did FDA clear under K261673?

K261673 is the FDA 510(k) for LED Therapy Device (QLXY-01), submitted by Beijing Nubway S&T Co., Ltd.. FDA's decision date was Sep 17, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the LED Therapy Device (QLXY-01)?

Beijing Nubway S&T Co., Ltd., based in Beijing, is the applicant of record for K261673.

How long did the K261673 review take?

FDA received the submission on May 21, 2026 and issued its decision on Sep 17, 2026, 119 days later.

← All decisions in September 2026

Sources