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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 / K253000

510(k) cleared

CryoFreeze Wart and Skin Tag Remover

Cryosurgery, Inc. · Oct 16, 2025 · K253000

FDA cleared the CryoFreeze Wart and Skin Tag Remover from Cryosurgery, Inc. on Oct 16, 2025 under K253000, a special 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 Sep 18, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

Cryosurgery, Inc. has one other decision in the tracker over the last 12 months: K252903 (Verruca-Freeze H Plus).

Questions & Answers

What did FDA clear under K253000?

K253000 is the FDA 510(k) for CryoFreeze Wart and Skin Tag Remover, submitted by Cryosurgery, Inc.. FDA's decision date was Oct 16, 2025, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the CryoFreeze Wart and Skin Tag Remover?

Cryosurgery, Inc., based in Nashville, TN, is the applicant of record for K253000.

How long did the K253000 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Oct 16, 2025, 28 days later.

← All decisions in October 2025

Sources