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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 / March 2026 / K260765

510(k) cleared

Gemini NOVA 810+980 Soft Tissue Laser

Azena Medical, LLC · Mar 10, 2026 · K260765

FDA cleared the Gemini NOVA 810+980 Soft Tissue Laser from Azena Medical, LLC on Mar 10, 2026 under K260765, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code NVK, Laser, Dental, Soft Tissue, 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 9, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Azena Medical, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260765?

K260765 is the FDA 510(k) for Gemini NOVA 810+980 Soft Tissue Laser, submitted by Azena Medical, LLC. FDA's decision date was Mar 10, 2026, under product code NVK (Laser, Dental, Soft Tissue).

Who makes the Gemini NOVA 810+980 Soft Tissue Laser?

Azena Medical, LLC, based in Walnut Creek, CA, is the applicant of record for K260765.

How long did the K260765 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Mar 10, 2026, 1 days later.

← All decisions in March 2026