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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 / June 2026 / K261570

510(k) cleared

PICOSURE WORKSTATION

Cynosure, LLC · Jun 17, 2026 · K261570

FDA cleared the PICOSURE WORKSTATION from Cynosure, LLC on Jun 17, 2026 under K261570, a special 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 May 12, 2026. The decision came 36 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K261570?

K261570 is the FDA 510(k) for PICOSURE WORKSTATION, submitted by Cynosure, LLC. FDA's decision date was Jun 17, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the PICOSURE WORKSTATION?

Cynosure, LLC, based in Wesford, MA, is the applicant of record for K261570.

How long did the K261570 review take?

FDA received the submission on May 12, 2026 and issued its decision on Jun 17, 2026, 36 days later.

← All decisions in June 2026