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 / April 2026 / K260129

510(k) cleared

Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

Shenzhen Kaiyan Medical Equipment Co., Ltd. · Apr 15, 2026 · K260129

FDA cleared the Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) from Shenzhen Kaiyan Medical Equipment Co., Ltd. on Apr 15, 2026 under K260129, a traditional 510(k). The device falls under product code OLI, Fat Reducing Low Level Laser, regulated at 21 CFR 878.5400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jan 16, 2026. The decision came 89 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)), K253878 (LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)).

Questions & Answers

What did FDA clear under K260129?

K260129 is the FDA 510(k) for Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd.. FDA's decision date was Apr 15, 2026, under product code OLI (Fat Reducing Low Level Laser).

Who makes the Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )?

Shenzhen Kaiyan Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K260129.

How long did the K260129 review take?

FDA received the submission on Jan 16, 2026 and issued its decision on Apr 15, 2026, 89 days later.

← All decisions in April 2026