DEN250016 is an FDA 510(k) submission for the Essilor® Stellest®. This device is classified as a Prescription Spectacle Lenses To Reduce The Progression Of Myopia (Class II - Special Controls, product code QUR).
Submitted by Essilor of America, Inc. (Dallas, US). The FDA issued a Not Cleared (DENG) decision on September 25, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5845. 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..
| 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 | - |
| Product Code | QUR - Prescription Spectacle Lenses To Reduce The Progression Of Myopia |
| Device Class | Class II - 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. |