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 / June 2026 / K254025

510(k) cleared

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jun 16, 2026 · K254025

FDA cleared the LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) from Shenzhen Kaiyan Medical Equipment Co., Ltd. on Jun 16, 2026 under K254025, 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 Dec 16, 2025. The decision came 182 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Shenzhen Kaiyan Medical Equipment Co., Ltd. has 8 other decisions in the tracker over the last 12 months: K253932 (FACEGYM Pro Device (HD-109)), 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 )), K253878 (LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)).

Questions & Answers

What did FDA clear under K254025?

K254025 is the FDA 510(k) for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd.. FDA's decision date was Jun 16, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)?

Shenzhen Kaiyan Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K254025.

How long did the K254025 review take?

FDA received the submission on Dec 16, 2025 and issued its decision on Jun 16, 2026, 182 days later.

← All decisions in June 2026