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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 / May 2026 / K260688

510(k) cleared

Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)

Shenzhen Kaiyan Medical Equipment Co., Ltd. · May 4, 2026 · K260688

FDA cleared the Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) from Shenzhen Kaiyan Medical Equipment Co., Ltd. on May 4, 2026 under K260688, 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 Mar 3, 2026. The decision came 62 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)), K260129 (Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )), K253878 (LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)).

Questions & Answers

What did FDA clear under K260688?

K260688 is the FDA 510(k) for Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd.. FDA's decision date was May 4, 2026, under product code OLI (Fat Reducing Low Level Laser).

Who makes the Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)?

Shenzhen Kaiyan Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K260688.

How long did the K260688 review take?

FDA received the submission on Mar 3, 2026 and issued its decision on May 4, 2026, 62 days later.

← All decisions in May 2026