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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 / K253165

510(k) cleared

LAP-iX2N

Sejong Medical Co., Ltd. · Jun 9, 2026 · K253165

FDA cleared the LAP-iX2N from Sejong Medical Co., Ltd. on Jun 9, 2026 under K253165, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 26, 2025. The decision came 256 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sejong Medical Co., Ltd. has one other decision in the tracker over the last 12 months: K252985 (Laport).

Questions & Answers

What did FDA clear under K253165?

K253165 is the FDA 510(k) for LAP-iX2N, submitted by Sejong Medical Co., Ltd.. FDA's decision date was Jun 9, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the LAP-iX2N?

Sejong Medical Co., Ltd., based in Gyeonggi-Do, is the applicant of record for K253165.

How long did the K253165 review take?

FDA received the submission on Sep 26, 2025 and issued its decision on Jun 9, 2026, 256 days later.

← All decisions in June 2026

Sources