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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 / P240045

PMA approved

Optimum Infinite (tisilfocon A) Orthokeratology Lenses II

Contamac, Ltd. · Feb 10, 2026 · P240045

FDA approved the Optimum Infinite (tisilfocon A) Orthokeratology Lenses II from Contamac, Ltd. on Feb 10, 2026 under P240045, an original premarket approval. The device falls under product code NUU, Lens, Contact, Orthokeratology, Overnight, regulated at 21 CFR 886.5916 as a Class 3 device. The review panel was Ophthalmic.

FDA logged the submission as received on Dec 17, 2024. The decision came 420 days later.

This is the only decision on file for Contamac, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P240045?

P240045 is the FDA PMA for Optimum Infinite (tisilfocon A) Orthokeratology Lenses II, submitted by Contamac, Ltd.. FDA's decision date was Feb 10, 2026, under product code NUU (Lens, Contact, Orthokeratology, Overnight).

Who makes the Optimum Infinite (tisilfocon A) Orthokeratology Lenses II?

Contamac, Ltd., based in Saffron Walden, is the applicant of record for P240045.

How long did the P240045 review take?

FDA received the submission on Dec 17, 2024 and issued its decision on Feb 10, 2026, 420 days later.

← All decisions in February 2026