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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 / October 2025 / K250852

510(k) cleared

Coolfase

Asterasys Co., Ltd. · Oct 16, 2025 · K250852

FDA cleared the Coolfase from Asterasys Co., Ltd. on Oct 16, 2025 under K250852, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 21, 2025. The decision came 209 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Asterasys Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250852?

K250852 is the FDA 510(k) for Coolfase, submitted by Asterasys Co., Ltd.. FDA's decision date was Oct 16, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Coolfase?

Asterasys Co., Ltd., based in Seoul, is the applicant of record for K250852.

How long did the K250852 review take?

FDA received the submission on Mar 21, 2025 and issued its decision on Oct 16, 2025, 209 days later.

← All decisions in October 2025