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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 / December 2025 / K253349

510(k) cleared

Hair Regrowth Cap (Model: T-119-HRC)

Light Tree Ventures Europe B.V. · Dec 24, 2025 · K253349

FDA cleared the Hair Regrowth Cap (Model: T-119-HRC) from Light Tree Ventures Europe B.V. on Dec 24, 2025 under K253349, 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 30, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Light Tree Ventures Europe B.V. has one other decision in the tracker over the last 12 months: K260415 (myLEDmask 2 (MJ-144)).

Questions & Answers

What did FDA clear under K253349?

K253349 is the FDA 510(k) for Hair Regrowth Cap (Model: T-119-HRC), submitted by Light Tree Ventures Europe B.V.. FDA's decision date was Dec 24, 2025, under product code OAP (Laser, Comb, Hair).

Who makes the Hair Regrowth Cap (Model: T-119-HRC)?

Light Tree Ventures Europe B.V., based in Den Haag, is the applicant of record for K253349.

How long did the K253349 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 24, 2025, 85 days later.

← All decisions in December 2025

Sources