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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 / K253669

510(k) cleared

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jan 23, 2026 · K253669

FDA cleared the TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) from Shenzhen Kaiyan Medical Equipment Co., Ltd. on Jan 23, 2026 under K253669, a traditional 510(k). The device falls under product code OAP, Laser, Comb, Hair, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Nov 21, 2025. The decision came 63 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)), K260129 (Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )).

Questions & Answers

What did FDA clear under K253669?

K253669 is the FDA 510(k) for TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd.. FDA's decision date was Jan 23, 2026, under product code OAP (Laser, Comb, Hair).

Who makes the TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)?

Shenzhen Kaiyan Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K253669.

How long did the K253669 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Jan 23, 2026, 63 days later.

← All decisions in January 2026