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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261674

510(k) cleared

Skin Air Cooling System (QALF-01)

Beijing Nubway S&T Co., Ltd. · Jul 16, 2026 · K261674

FDA cleared the Skin Air Cooling System (QALF-01) from Beijing Nubway S&T Co., Ltd. on Jul 16, 2026 under K261674, 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 56 days later, inside the 90 FDA-day goal for a 510(k).

Beijing Nubway S&T Co., Ltd. has 2 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)).

Questions & Answers

What did FDA clear under K261674?

K261674 is the FDA 510(k) for Skin Air Cooling System (QALF-01), submitted by Beijing Nubway S&T Co., Ltd.. FDA's decision date was Jul 16, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Skin Air Cooling System (QALF-01)?

Beijing Nubway S&T Co., Ltd., based in Beijing, is the applicant of record for K261674.

How long did the K261674 review take?

FDA received the submission on May 21, 2026 and issued its decision on Jul 16, 2026, 56 days later.

← All decisions in July 2026

Sources