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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 / September 2025 / K251758

510(k) cleared

Serafin®

Tns Co., Ltd. · Sep 11, 2025 · K251758

FDA cleared the Serafin® from Tns Co., Ltd. on Sep 11, 2025 under K251758, a traditional 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 9, 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 Tns Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251758?

K251758 is the FDA 510(k) for Serafin®, submitted by Tns Co., Ltd.. FDA's decision date was Sep 11, 2025, under product code NXC (Aligner, Sequential).

Who makes the Serafin®?

Tns Co., Ltd., based in Seoul, is the applicant of record for K251758.

How long did the K251758 review take?

FDA received the submission on Jun 9, 2025 and issued its decision on Sep 11, 2025, 94 days later.

← All decisions in September 2025