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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 / June 2026 / K253231

510(k) cleared

Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)

Hubei Yjt Technology Co.,Ltd · Jun 16, 2026 · K253231

FDA cleared the Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500) from Hubei Yjt Technology Co.,Ltd on Jun 16, 2026 under K253231, 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 Sep 29, 2025. The decision came 260 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Hubei Yjt Technology Co.,Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253231?

K253231 is the FDA 510(k) for Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500), submitted by Hubei Yjt Technology Co.,Ltd. FDA's decision date was Jun 16, 2026, under product code OAP (Laser, Comb, Hair).

Who makes the Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)?

Hubei Yjt Technology Co.,Ltd, based in Wuhan, is the applicant of record for K253231.

How long did the K253231 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Jun 16, 2026, 260 days later.

← All decisions in June 2026