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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 / January 2026 / K252603

510(k) cleared

HIGHERDOSE Body Sculptor (Model: GS-03)

Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jan 28, 2026 · K252603

FDA cleared the HIGHERDOSE Body Sculptor (Model: GS-03) from Shenzhen Kaiyan Medical Equipment Co., Ltd. on Jan 28, 2026 under K252603, 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 Aug 18, 2025. The decision came 163 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)), 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 K252603?

K252603 is the FDA 510(k) for HIGHERDOSE Body Sculptor (Model: GS-03), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd.. FDA's decision date was Jan 28, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the HIGHERDOSE Body Sculptor (Model: GS-03)?

Shenzhen Kaiyan Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K252603.

How long did the K252603 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Jan 28, 2026, 163 days later.

← All decisions in January 2026