FDA product code QUR: 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. It is a Class II device, regulated under 21 CFR 886.5845 and reviewed by the Ophthalmic panel. Devices under QUR reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Prescription Spectacle Lenses To Reduce The Progression Of Myopia |
| Device class | Class II |
| Regulation | 21 CFR 886.5845 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
Recalls for QUR devices
openFDA lists no recalls for product code QUR.
Frequently asked questions
What is FDA product code QUR?
QUR is the FDA product code for prescription spectacle lenses to reduce the progression of myopia. It is a Class II device, regulated under 21 CFR 886.5845 and reviewed by the Ophthalmic panel.
What device class is QUR?
Class II, regulation 21 CFR 886.5845. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code QUR
- Run a recall and safety report across every QUR manufacturer
- Watch product code QUR for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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