WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / December 2025 / K253054

510(k) cleared

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. · Dec 19, 2025 · K253054

FDA cleared the LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) from Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. on Dec 19, 2025 under K253054, 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 Sep 22, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253054?

K253054 is the FDA 510(k) for LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6), submitted by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.. FDA's decision date was Dec 19, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)?

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., based in Shenzhen, is the applicant of record for K253054.

How long did the K253054 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Dec 19, 2025, 88 days later.

← All decisions in December 2025