WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K250618

510(k) cleared

Medi Lift Essential Eye Mask

Ya-Man, Ltd. · Oct 29, 2025 · K250618

FDA cleared the Medi Lift Essential Eye Mask from Ya-Man, Ltd. on Oct 29, 2025 under K250618, a traditional 510(k). The device falls under product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Feb 28, 2025. The decision came 243 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 Ya-Man, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250618?

K250618 is the FDA 510(k) for Medi Lift Essential Eye Mask, submitted by Ya-Man, Ltd.. FDA's decision date was Oct 29, 2025, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the Medi Lift Essential Eye Mask?

Ya-Man, Ltd., based in Tokyo, is the applicant of record for K250618.

How long did the K250618 review take?

FDA received the submission on Feb 28, 2025 and issued its decision on Oct 29, 2025, 243 days later.

← All decisions in October 2025