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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 / September 2025 / P240038

PMA approved

FINEVISION HP Trifocal IOLs

Beaver Visitec International, Inc. · Sep 10, 2025 · P240038

FDA approved the FINEVISION HP Trifocal IOLs from Beaver Visitec International, Inc. on Sep 10, 2025 under P240038, an original premarket approval. The device falls under product code HQL, Intraocular Lens, regulated at 21 CFR 886.3600 as a Class 3 device. The review panel was Ophthalmic.

FDA logged the submission as received on Oct 30, 2024. The decision came 315 days later.

This is the only decision on file for Beaver Visitec International, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P240038?

P240038 is the FDA PMA for FINEVISION HP Trifocal IOLs, submitted by Beaver Visitec International, Inc.. FDA's decision date was Sep 10, 2025, under product code HQL (Intraocular Lens).

Who makes the FINEVISION HP Trifocal IOLs?

Beaver Visitec International, Inc., based in Waltham, MA, is the applicant of record for P240038.

How long did the P240038 review take?

FDA received the submission on Oct 30, 2024 and issued its decision on Sep 10, 2025, 315 days later.

← All decisions in September 2025