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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 / June 2026 / K260715

510(k) cleared

CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)

The Beauty Tech Group, Ltd. · Jun 3, 2026 · K260715

FDA cleared the CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) from The Beauty Tech Group, Ltd. on Jun 3, 2026 under K260715, 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 Mar 5, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for The Beauty Tech Group, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260715?

K260715 is the FDA 510(k) for CurrentBody Skin LED Multi Light Therapy Mask (MK-110D), submitted by The Beauty Tech Group, Ltd.. FDA's decision date was Jun 3, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)?

The Beauty Tech Group, Ltd., based in Macclesfield, is the applicant of record for K260715.

How long did the K260715 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on Jun 3, 2026, 90 days later.

← All decisions in June 2026