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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 / K253333

510(k) cleared

Assisted Reproduction Laser System (Model ILS-400M)

Hua Yue Medical Technology Co., Ltd. · Jun 17, 2026 · K253333

FDA cleared the Assisted Reproduction Laser System (Model ILS-400M) from Hua Yue Medical Technology Co., Ltd. on Jun 17, 2026 under K253333, a traditional 510(k). The device falls under product code MRX, System, Assisted Reproduction Laser, regulated at 21 CFR 884.6200 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Sep 30, 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 Hua Yue Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253333?

K253333 is the FDA 510(k) for Assisted Reproduction Laser System (Model ILS-400M), submitted by Hua Yue Medical Technology Co., Ltd.. FDA's decision date was Jun 17, 2026, under product code MRX (System, Assisted Reproduction Laser).

Who makes the Assisted Reproduction Laser System (Model ILS-400M)?

Hua Yue Medical Technology Co., Ltd., based in Guangzhou, is the applicant of record for K253333.

How long did the K253333 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jun 17, 2026, 260 days later.

← All decisions in June 2026