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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 / April 2026 / K261094

510(k) cleared

YellowStar

Asclepion Laser Technologies GmbH · Apr 29, 2026 · K261094

FDA cleared the YellowStar from Asclepion Laser Technologies GmbH on Apr 29, 2026 under K261094, 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 Apr 2, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Asclepion Laser Technologies GmbH has one other decision in the tracker over the last 12 months: K253100 (MultiPulse TFL).

Questions & Answers

What did FDA clear under K261094?

K261094 is the FDA 510(k) for YellowStar, submitted by Asclepion Laser Technologies GmbH. FDA's decision date was Apr 29, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the YellowStar?

Asclepion Laser Technologies GmbH, based in Jena, is the applicant of record for K261094.

How long did the K261094 review take?

FDA received the submission on Apr 2, 2026 and issued its decision on Apr 29, 2026, 27 days later.

← All decisions in April 2026

Sources