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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 / February 2026 / K253683

510(k) cleared

FAQ (LED Panel); FAQ (Dual LED Panel)

Foreo, Inc. · Feb 20, 2026 · K253683

FDA cleared the FAQ (LED Panel); FAQ (Dual LED Panel) from Foreo, Inc. on Feb 20, 2026 under K253683, 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 Nov 21, 2025. The decision came 91 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 Foreo, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253683?

K253683 is the FDA 510(k) for FAQ (LED Panel); FAQ (Dual LED Panel), submitted by Foreo, Inc.. FDA's decision date was Feb 20, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the FAQ (LED Panel); FAQ (Dual LED Panel)?

Foreo, Inc., based in Las Vegas, NV, is the applicant of record for K253683.

How long did the K253683 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Feb 20, 2026, 91 days later.

← All decisions in February 2026