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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 / January 2026 / K251353

510(k) cleared

Eyer 2

Phelcom Technologies · Jan 16, 2026 · K251353

FDA cleared the Eyer 2 from Phelcom Technologies on Jan 16, 2026 under K251353, a traditional 510(k). The device falls under product code HKI, Camera, Ophthalmic, Ac-Powered, regulated at 21 CFR 886.1120 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Apr 30, 2025. The decision came 261 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 Phelcom Technologies in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251353?

K251353 is the FDA 510(k) for Eyer 2, submitted by Phelcom Technologies. FDA's decision date was Jan 16, 2026, under product code HKI (Camera, Ophthalmic, Ac-Powered).

Who makes the Eyer 2?

Phelcom Technologies, based in São Carlos, is the applicant of record for K251353.

How long did the K251353 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Jan 16, 2026, 261 days later.

← All decisions in January 2026