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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 / November 2025 / K252308

510(k) cleared

LED Beauty Mask (RLBXX)

Atop Lighting Co., Ltd. · Nov 13, 2025 · K252308

FDA cleared the LED Beauty Mask (RLBXX) from Atop Lighting Co., Ltd. on Nov 13, 2025 under K252308, 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 Jul 24, 2025. The decision came 112 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 Atop Lighting Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252308?

K252308 is the FDA 510(k) for LED Beauty Mask (RLBXX), submitted by Atop Lighting Co., Ltd.. FDA's decision date was Nov 13, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Beauty Mask (RLBXX)?

Atop Lighting Co., Ltd., based in Shenzhen City, is the applicant of record for K252308.

How long did the K252308 review take?

FDA received the submission on Jul 24, 2025 and issued its decision on Nov 13, 2025, 112 days later.

← All decisions in November 2025