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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 / K252325

510(k) cleared

Hair Growth Laser Cap

Cosmo Far East Technology Limited · Oct 22, 2025 · K252325

FDA cleared the Hair Growth Laser Cap from Cosmo Far East Technology Limited on Oct 22, 2025 under K252325, 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 Jul 25, 2025. The decision came 89 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cosmo Far East Technology Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252325?

K252325 is the FDA 510(k) for Hair Growth Laser Cap, submitted by Cosmo Far East Technology Limited. FDA's decision date was Oct 22, 2025, under product code OAP (Laser, Comb, Hair).

Who makes the Hair Growth Laser Cap?

Cosmo Far East Technology Limited, based in Shenzhen, is the applicant of record for K252325.

How long did the K252325 review take?

FDA received the submission on Jul 25, 2025 and issued its decision on Oct 22, 2025, 89 days later.

← All decisions in October 2025