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THE TAPE

FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262426

510(k) cleared

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

Wuhan Pioon Technology Co., Ltd. · Sep 10, 2026 · K262426

FDA cleared the Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) from Wuhan Pioon Technology Co., Ltd. on Sep 10, 2026 under K262426, 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 Jul 16, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Wuhan Pioon Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262426?

K262426 is the FDA 510(k) for Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75), submitted by Wuhan Pioon Technology Co., Ltd.. FDA's decision date was Sep 10, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)?

Wuhan Pioon Technology Co., Ltd., based in Wuhan, is the applicant of record for K262426.

How long did the K262426 review take?

FDA received the submission on Jul 16, 2026 and issued its decision on Sep 10, 2026, 56 days later.

← All decisions in September 2026