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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 / K253391

510(k) cleared

Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)

Medtronic Navigation, Inc. · Mar 13, 2026 · K253391

FDA cleared the Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561) from Medtronic Navigation, Inc. on Mar 13, 2026 under K253391, a traditional 510(k). The device falls under product code ONO, Neurosurgical Laser With Mr Thermography, 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 Sep 30, 2025. The decision came 164 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Navigation, Inc. has 4 other decisions in the tracker over the last 12 months: K253379 (Stealth AXiS Cranial clinical application), K253395 (Stealth AXiS ENT clinical application), K253381 (Stealth AXiS Surgical System with Stealth AXiS Spine clinical application), K251282 (StealthStation S8 Spine Software).

Questions & Answers

What did FDA clear under K253391?

K253391 is the FDA 510(k) for Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561), submitted by Medtronic Navigation, Inc.. FDA's decision date was Mar 13, 2026, under product code ONO (Neurosurgical Laser With Mr Thermography).

Who makes the Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator System (9735560); Visualase Cooled Laser Applicator System (9735561)?

Medtronic Navigation, Inc., based in Lafayette, CO, is the applicant of record for K253391.

How long did the K253391 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Mar 13, 2026, 164 days later.

← All decisions in March 2026

Sources