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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 / December 2025 / K252983

510(k) cleared

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)

Shenzhen Goodwind Technology Development Co., Ltd. · Dec 17, 2025 · K252983

FDA cleared the Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) from Shenzhen Goodwind Technology Development Co., Ltd. on Dec 17, 2025 under K252983, 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 18, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Goodwind Technology Development Co., Ltd. has one other decision in the tracker over the last 12 months: K261602 (Eye Recovery Pro (PH-e03)).

Questions & Answers

What did FDA clear under K252983?

K252983 is the FDA 510(k) for Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03), submitted by Shenzhen Goodwind Technology Development Co., Ltd.. FDA's decision date was Dec 17, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)?

Shenzhen Goodwind Technology Development Co., Ltd., based in Shenzhen, is the applicant of record for K252983.

How long did the K252983 review take?

FDA received the submission on Sep 18, 2025 and issued its decision on Dec 17, 2025, 90 days later.

← All decisions in December 2025

Sources