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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 / April 2026 / K260153

510(k) cleared

Q-Switched Nd: YAG Laser System (Glamor Q)

Nanjing Bestview Laser S&T Co., Ltd. · Apr 20, 2026 · K260153

FDA cleared the Q-Switched Nd: YAG Laser System (Glamor Q) from Nanjing Bestview Laser S&T Co., Ltd. on Apr 20, 2026 under K260153, 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 Jan 20, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Nanjing Bestview Laser S&T Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260974 (CO2 Laser Machine (Monica-I,Monica-II)), K251919 (Thulium Laser System (Deluxlase)).

Questions & Answers

What did FDA clear under K260153?

K260153 is the FDA 510(k) for Q-Switched Nd: YAG Laser System (Glamor Q), submitted by Nanjing Bestview Laser S&T Co., Ltd.. FDA's decision date was Apr 20, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Q-Switched Nd: YAG Laser System (Glamor Q)?

Nanjing Bestview Laser S&T Co., Ltd., based in Nanjing Economic & Technological Develop, is the applicant of record for K260153.

How long did the K260153 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Apr 20, 2026, 90 days later.

← All decisions in April 2026

Sources