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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 / May 2026 / K260974

510(k) cleared

CO2 Laser Machine (Monica-I,Monica-II)

Nanjing Bestview Laser S&T Co., Ltd. · May 7, 2026 · K260974

FDA cleared the CO2 Laser Machine (Monica-I,Monica-II) from Nanjing Bestview Laser S&T Co., Ltd. on May 7, 2026 under K260974, 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 Mar 24, 2026. The decision came 44 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: K260153 (Q-Switched Nd: YAG Laser System (Glamor Q)), K251919 (Thulium Laser System (Deluxlase)).

Questions & Answers

What did FDA clear under K260974?

K260974 is the FDA 510(k) for CO2 Laser Machine (Monica-I,Monica-II), submitted by Nanjing Bestview Laser S&T Co., Ltd.. FDA's decision date was May 7, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CO2 Laser Machine (Monica-I,Monica-II)?

Nanjing Bestview Laser S&T Co., Ltd., based in Nanjing, is the applicant of record for K260974.

How long did the K260974 review take?

FDA received the submission on Mar 24, 2026 and issued its decision on May 7, 2026, 44 days later.

← All decisions in May 2026

Sources