WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / DEN250016

510(k) cleared

Essilor® Stellest®

Essilor Of America, Inc. · Sep 25, 2025 · DEN250016

FDA cleared the Essilor® Stellest® from Essilor Of America, Inc. on Sep 25, 2025 under DEN250016, a direct 510(k). The device falls under product code QUR, Prescription Spectacle Lenses To Reduce The Progression Of Myopia, regulated at 21 CFR 886.5845 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Apr 28, 2025. The decision came 150 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 Essilor Of America, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250016?

DEN250016 is the FDA 510(k) for Essilor® Stellest®, submitted by Essilor Of America, Inc.. FDA's decision date was Sep 25, 2025, under product code QUR (Prescription Spectacle Lenses To Reduce The Progression Of Myopia).

Who makes the Essilor® Stellest®?

Essilor Of America, Inc., based in Dallas, TX, is the applicant of record for DEN250016.

How long did the DEN250016 review take?

FDA received the submission on Apr 28, 2025 and issued its decision on Sep 25, 2025, 150 days later.

← All decisions in September 2025