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THE TAPE

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 / K251730

510(k) cleared

LIA Console (542-7)

Leadoptik, Inc. · Dec 19, 2025 · K251730

FDA cleared the LIA Console (542-7) from Leadoptik, Inc. on Dec 19, 2025 under K251730, a traditional 510(k). The device falls under product code NQQ, System, Imaging, Optical Coherence Tomography (Oct), regulated at 21 CFR 892.1560 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jun 6, 2025. The decision came 196 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Leadoptik, Inc. has one other decision in the tracker over the last 12 months: K251402 (LIA-1 Catheter (542-1)).

Questions & Answers

What did FDA clear under K251730?

K251730 is the FDA 510(k) for LIA Console (542-7), submitted by Leadoptik, Inc.. FDA's decision date was Dec 19, 2025, under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)).

Who makes the LIA Console (542-7)?

Leadoptik, Inc., based in San Jose, CA, is the applicant of record for K251730.

How long did the K251730 review take?

FDA received the submission on Jun 6, 2025 and issued its decision on Dec 19, 2025, 196 days later.

← All decisions in December 2025

Sources