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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 / K252786

510(k) cleared

Led Light Phototherapy Bed (Pro 450/ GY-680A)

Shenzhen Suyzeko Limited. · Dec 1, 2025 · K252786

FDA cleared the Led Light Phototherapy Bed (Pro 450/ GY-680A) from Shenzhen Suyzeko Limited. on Dec 1, 2025 under K252786, 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 Sep 2, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Suyzeko Limited. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252786?

K252786 is the FDA 510(k) for Led Light Phototherapy Bed (Pro 450/ GY-680A), submitted by Shenzhen Suyzeko Limited.. FDA's decision date was Dec 1, 2025, under product code OLI (Fat Reducing Low Level Laser).

Who makes the Led Light Phototherapy Bed (Pro 450/ GY-680A)?

Shenzhen Suyzeko Limited., based in Shenzhen, is the applicant of record for K252786.

How long did the K252786 review take?

FDA received the submission on Sep 2, 2025 and issued its decision on Dec 1, 2025, 90 days later.

← All decisions in December 2025