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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 / October 2025 / K252414

510(k) cleared

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

Shenzhen Kaiyan Medical Equipment Co., Ltd. · Oct 30, 2025 · K252414

FDA cleared the Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) from Shenzhen Kaiyan Medical Equipment Co., Ltd. on Oct 30, 2025 under K252414, 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 Aug 1, 2025. The decision came 90 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 K252414?

K252414 is the FDA 510(k) for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd.. FDA's decision date was Oct 30, 2025, under product code OAP (Laser, Comb, Hair).

Who makes the Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

Shenzhen Kaiyan Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K252414.

How long did the K252414 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Oct 30, 2025, 90 days later.

← All decisions in October 2025