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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 / January 2026 / K251524

510(k) cleared

Dr. Yglo Skin Tag Remover

Theotclab Healthcare B.V. · Jan 12, 2026 · K251524

FDA cleared the Dr. Yglo Skin Tag Remover from Theotclab Healthcare B.V. on Jan 12, 2026 under K251524, 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 May 16, 2025. The decision came 241 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 Theotclab Healthcare B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251524?

K251524 is the FDA 510(k) for Dr. Yglo Skin Tag Remover, submitted by Theotclab Healthcare B.V.. FDA's decision date was Jan 12, 2026, under product code GEH (Unit, Cryosurgical, Accessories).

Who makes the Dr. Yglo Skin Tag Remover?

Theotclab Healthcare B.V., based in Amsterdam, is the applicant of record for K251524.

How long did the K251524 review take?

FDA received the submission on May 16, 2025 and issued its decision on Jan 12, 2026, 241 days later.

← All decisions in January 2026