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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 / August 2026 / K261602

510(k) cleared

Eye Recovery Pro (PH-e03)

Shenzhen Goodwind Technology Development Co., Ltd. · Aug 10, 2026 · K261602

FDA cleared the Eye Recovery Pro (PH-e03) from Shenzhen Goodwind Technology Development Co., Ltd. on Aug 10, 2026 under K261602, 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 May 14, 2026. The decision came 88 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: K252983 (Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)).

Questions & Answers

What did FDA clear under K261602?

K261602 is the FDA 510(k) for Eye Recovery Pro (PH-e03), submitted by Shenzhen Goodwind Technology Development Co., Ltd.. FDA's decision date was Aug 10, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the Eye Recovery Pro (PH-e03)?

Shenzhen Goodwind Technology Development Co., Ltd., based in Shenzhen, is the applicant of record for K261602.

How long did the K261602 review take?

FDA received the submission on May 14, 2026 and issued its decision on Aug 10, 2026, 88 days later.

← All decisions in August 2026

Sources