Prescription Spectacle Lenses To Reduce The Progression Of Myopia
QUR is the FDA product code for Prescription Spectacle Lenses To Reduce The Progression Of Myopia, a class II device type, regulated under 21 CFR 886.5845. FDA's definition for this code reads: "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...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- QUR
- Device name
- Prescription Spectacle Lenses To Reduce The Progression Of Myopia
- FDA 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.
- Regulation
- 21 CFR 886.5845
- Device class
- Class II
- Review panel
- Ophthalmic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code QUR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code QUR| Applicant | Clearances |
|---|---|
| Essilor of America, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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