QUR — Prescription Spectacle Lenses To Reduce The Progression Of Myopia Class II
FDA product code QUR covers "Prescription Spectacle Lenses To Reduce The Progression Of Myopia", a Class II medical device regulated under 21 CFR 886.5845. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QUR
- Device Class
- Class II
- Regulation Number
- 886.5845
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250016 | essilor of america | Essilor® Stellest® | September 25, 2025 |