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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 / December 2025 / K250742

510(k) cleared

Focused Cryotherapy System

Focused Cryo, Inc. · Dec 9, 2025 · K250742

FDA cleared the Focused Cryotherapy System from Focused Cryo, Inc. on Dec 9, 2025 under K250742, a traditional 510(k). The device falls under product code GEH, Unit, Cryosurgical, Accessories, regulated at 21 CFR 878.4350 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 11, 2025. The decision came 273 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 Focused Cryo, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250742?

K250742 is the FDA 510(k) for Focused Cryotherapy System, submitted by Focused Cryo, Inc.. FDA's decision date was Dec 9, 2025, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the Focused Cryotherapy System?

Focused Cryo, Inc., based in Marietta, GA, is the applicant of record for K250742.

How long did the K250742 review take?

FDA received the submission on Mar 11, 2025 and issued its decision on Dec 9, 2025, 273 days later.

← All decisions in December 2025