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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 / February 2026 / K253666

510(k) cleared

IPL Hair Removal Device (Models: T31A, T32A)

Shenzhen Mlay Intelligent Technology Co., Ltd. · Feb 23, 2026 · K253666

FDA cleared the IPL Hair Removal Device (Models: T31A, T32A) from Shenzhen Mlay Intelligent Technology Co., Ltd. on Feb 23, 2026 under K253666, a traditional 510(k). The device falls under product code OHT, Light Based Over-The-Counter Hair Removal, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Nov 21, 2025. The decision came 94 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 Shenzhen Mlay Intelligent Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253666?

K253666 is the FDA 510(k) for IPL Hair Removal Device (Models: T31A, T32A), submitted by Shenzhen Mlay Intelligent Technology Co., Ltd.. FDA's decision date was Feb 23, 2026, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the IPL Hair Removal Device (Models: T31A, T32A)?

Shenzhen Mlay Intelligent Technology Co., Ltd., based in Shenzhen, is the applicant of record for K253666.

How long did the K253666 review take?

FDA received the submission on Nov 21, 2025 and issued its decision on Feb 23, 2026, 94 days later.

← All decisions in February 2026