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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 / March 2026 / K253960

510(k) cleared

Medicell Mycosis Laser (MCML24004)

Medicell Healthcare Co.,LTD · Mar 9, 2026 · K253960

FDA cleared the Medicell Mycosis Laser (MCML24004) from Medicell Healthcare Co.,LTD on Mar 9, 2026 under K253960, a traditional 510(k). The device falls under product code PDZ, Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis, 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 Dec 10, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Medicell Healthcare Co.,LTD in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253960?

K253960 is the FDA 510(k) for Medicell Mycosis Laser (MCML24004), submitted by Medicell Healthcare Co.,LTD. FDA's decision date was Mar 9, 2026, under product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis).

Who makes the Medicell Mycosis Laser (MCML24004)?

Medicell Healthcare Co.,LTD, based in Incheon, is the applicant of record for K253960.

How long did the K253960 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Mar 9, 2026, 89 days later.

← All decisions in March 2026