WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / August 2026 / K261841

510(k) cleared

Q Switched Nd:YAG Laser machine (QLQW-01)

Beijing Nubway S&T Co., Ltd. · Aug 11, 2026 · K261841

FDA cleared the Q Switched Nd:YAG Laser machine (QLQW-01) from Beijing Nubway S&T Co., Ltd. on Aug 11, 2026 under K261841, 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 Jun 3, 2026. The decision came 69 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: K261693 (Diode laser hair removal machine (QDTM-04)), K261674 (Skin Air Cooling System (QALF-01)).

Questions & Answers

What did FDA clear under K261841?

K261841 is the FDA 510(k) for Q Switched Nd:YAG Laser machine (QLQW-01), submitted by Beijing Nubway S&T Co., Ltd.. FDA's decision date was Aug 11, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Q Switched Nd:YAG Laser machine (QLQW-01)?

Beijing Nubway S&T Co., Ltd., based in Beijing, is the applicant of record for K261841.

How long did the K261841 review take?

FDA received the submission on Jun 3, 2026 and issued its decision on Aug 11, 2026, 69 days later.

← All decisions in August 2026

Sources