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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 / March 2026 / K251848

510(k) cleared

Pentacam® Cornea OCT

Oculus Optikgeräte GmbH · Mar 13, 2026 · K251848

FDA cleared the Pentacam® Cornea OCT from Oculus Optikgeräte GmbH on Mar 13, 2026 under K251848, a traditional 510(k). The device falls under product code MXK, Device, Analysis, Anterior Segment, regulated at 21 CFR 886.1850 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Jun 16, 2025. The decision came 270 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 Oculus Optikgeräte GmbH in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251848?

K251848 is the FDA 510(k) for Pentacam® Cornea OCT, submitted by Oculus Optikgeräte GmbH. FDA's decision date was Mar 13, 2026, under product code MXK (Device, Analysis, Anterior Segment).

Who makes the Pentacam® Cornea OCT?

Oculus Optikgeräte GmbH, based in Wetzlar, is the applicant of record for K251848.

How long did the K251848 review take?

FDA received the submission on Jun 16, 2025 and issued its decision on Mar 13, 2026, 270 days later.

← All decisions in March 2026