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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 / K251573

510(k) cleared

VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens

Vizionfocus, Inc. · Sep 10, 2025 · K251573

FDA cleared the VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens from Vizionfocus, Inc. on Sep 10, 2025 under K251573, a traditional 510(k). The device falls under product code LPL, Lenses, Soft Contact, Daily Wear, regulated at 21 CFR 886.5925 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on May 22, 2025. The decision came 111 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 Vizionfocus, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251573?

K251573 is the FDA 510(k) for VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens, submitted by Vizionfocus, Inc.. FDA's decision date was Sep 10, 2025, under product code LPL (Lenses, Soft Contact, Daily Wear).

Who makes the VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens?

Vizionfocus, Inc., based in Miaoli County, is the applicant of record for K251573.

How long did the K251573 review take?

FDA received the submission on May 22, 2025 and issued its decision on Sep 10, 2025, 111 days later.

← All decisions in September 2025