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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 / September 2025 / K251919

510(k) cleared

Thulium Laser System (Deluxlase)

Nanjing Bestview Laser S&T Co., Ltd. · Sep 26, 2025 · K251919

FDA cleared the Thulium Laser System (Deluxlase) from Nanjing Bestview Laser S&T Co., Ltd. on Sep 26, 2025 under K251919, 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 23, 2025. The decision came 95 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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)), K260153 (Q-Switched Nd: YAG Laser System (Glamor Q)).

Questions & Answers

What did FDA clear under K251919?

K251919 is the FDA 510(k) for Thulium Laser System (Deluxlase), submitted by Nanjing Bestview Laser S&T Co., Ltd.. FDA's decision date was Sep 26, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Thulium Laser System (Deluxlase)?

Nanjing Bestview Laser S&T Co., Ltd., based in Nanjing, is the applicant of record for K251919.

How long did the K251919 review take?

FDA received the submission on Jun 23, 2025 and issued its decision on Sep 26, 2025, 95 days later.

← All decisions in September 2025

Sources