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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 / K251507

510(k) cleared

INTEGRE LIO

Quantel Medical · Feb 6, 2026 · K251507

FDA cleared the INTEGRE LIO from Quantel Medical on Feb 6, 2026 under K251507, a traditional 510(k). The device falls under product code HQF, Laser, Ophthalmic, regulated at 21 CFR 886.4390 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on May 16, 2025. The decision came 266 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 Quantel Medical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251507?

K251507 is the FDA 510(k) for INTEGRE LIO, submitted by Quantel Medical. FDA's decision date was Feb 6, 2026, under product code HQF (Laser, Ophthalmic).

Who makes the INTEGRE LIO?

Quantel Medical, based in Cournon D'Auvergne-Cedex, is the applicant of record for K251507.

How long did the K251507 review take?

FDA received the submission on May 16, 2025 and issued its decision on Feb 6, 2026, 266 days later.

← All decisions in February 2026