Not Cleared Direct

DEN250016 - Essilor® Stellest® (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN250016 · Essilor of America, Inc. · Ophthalmic device
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Sep 2025
Decision
150d
Days
Class 2
Risk

DEN250016 is an FDA 510(k) submission (not cleared) for the Essilor® Stellest®. Classified as Prescription Spectacle Lenses To Reduce The Progression Of Myopia (product code QUR), Class II - Special Controls.

Submitted by Essilor of America, Inc. (Dallas, US). The FDA issued a Not Cleared (DENG) decision on September 25, 2025 after a review of 150 days.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5845 - the FDA ophthalmic device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Ophthalmic review framework.

View all Essilor of America, Inc. devices

Submission Details

510(k) Number DEN250016 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 28, 2025
Decision Date September 25, 2025
Days to Decision 150 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 110d · This submission: 150d
Pathway characteristics

Device Classification

Product Code QUR Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5845
Definition Prescription Spectacle Lenses To Reduce The Progression Of Myopia Consist Of Spectacle Lenses With Additional Physical Optical Design Lens Elements. In Addition To Optical Correction Of Myopic Refractive Error, These Lenses Are Intended To Be Used By Children Who Have Myopia To Reduce The Rate Of Myopia Progression. The Lenses Are Mounted Within A Spectacle Frame Classified Under § 886.5842.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.