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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 / October 2025 / K252272

510(k) cleared

ORA Method LED Gua Sha (GS-04)

Shenzhen Kaiyan Medical Equipment Co., Ltd. · Oct 9, 2025 · K252272

FDA cleared the ORA Method LED Gua Sha (GS-04) from Shenzhen Kaiyan Medical Equipment Co., Ltd. on Oct 9, 2025 under K252272, 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 22, 2025. The decision came 79 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Kaiyan Medical Equipment Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K253932 (FACEGYM Pro Device (HD-109)), K254025 (LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)), K260688 (Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)), K260129 (Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )).

Questions & Answers

What did FDA clear under K252272?

K252272 is the FDA 510(k) for ORA Method LED Gua Sha (GS-04), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd.. FDA's decision date was Oct 9, 2025, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the ORA Method LED Gua Sha (GS-04)?

Shenzhen Kaiyan Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K252272.

How long did the K252272 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Oct 9, 2025, 79 days later.

← All decisions in October 2025