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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 / April 2026 / K260150

510(k) cleared

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

NOOANCE · Apr 22, 2026 · K260150

FDA cleared the LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) from NOOANCE on Apr 22, 2026 under K260150, 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 Jan 20, 2026. The decision came 92 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 NOOANCE in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260150?

K260150 is the FDA 510(k) for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C), submitted by NOOANCE. FDA's decision date was Apr 22, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

NOOANCE, based in Paris, is the applicant of record for K260150.

How long did the K260150 review take?

FDA received the submission on Jan 20, 2026 and issued its decision on Apr 22, 2026, 92 days later.

← All decisions in April 2026