510(k) DEN250016
DEN250016 is an FDA 510(k) premarket notification submitted by Essilor Of America, Inc. for the device "Essilor® Stellest®". The FDA issued a decision of De Novo Granted on Sep 25, 2025. The device falls under product code QUR (Prescription Spectacle Lenses To Reduce The Progression Of Myopia), a Class II device regulated under 21 CFR 886.5845.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Sep 25, 2025
- Date Received
- Apr 28, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prescription Spectacle Lenses To Reduce The Progression Of Myopia
- Device Class
- Class II
- Regulation Number
- 886.5845
- Review Panel
- OP
- Submission Type
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.