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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 / K254197

510(k) cleared

Picasso Pro Diode Laser (002-00460)

CAO Group, Inc. · Mar 11, 2026 · K254197

FDA cleared the Picasso Pro Diode Laser (002-00460) from CAO Group, Inc. on Mar 11, 2026 under K254197, 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 Dec 23, 2025. The decision came 78 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for CAO Group, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254197?

K254197 is the FDA 510(k) for Picasso Pro Diode Laser (002-00460), submitted by CAO Group, Inc.. FDA's decision date was Mar 11, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Picasso Pro Diode Laser (002-00460)?

CAO Group, Inc., based in West Jordan, UT, is the applicant of record for K254197.

How long did the K254197 review take?

FDA received the submission on Dec 23, 2025 and issued its decision on Mar 11, 2026, 78 days later.

← All decisions in March 2026