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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 / May 2026 / K260415

510(k) cleared

myLEDmask 2 (MJ-144)

Light Tree Ventures Europe B.V. · May 12, 2026 · K260415

FDA cleared the myLEDmask 2 (MJ-144) from Light Tree Ventures Europe B.V. on May 12, 2026 under K260415, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, 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 Feb 9, 2026. The decision came 92 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Light Tree Ventures Europe B.V. has one other decision in the tracker over the last 12 months: K253349 (Hair Regrowth Cap (Model: T-119-HRC)).

Questions & Answers

What did FDA clear under K260415?

K260415 is the FDA 510(k) for myLEDmask 2 (MJ-144), submitted by Light Tree Ventures Europe B.V.. FDA's decision date was May 12, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the myLEDmask 2 (MJ-144)?

Light Tree Ventures Europe B.V., based in Den Haag, is the applicant of record for K260415.

How long did the K260415 review take?

FDA received the submission on Feb 9, 2026 and issued its decision on May 12, 2026, 92 days later.

← All decisions in May 2026

Sources