Data / Medical devices / Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Prescription Spectacle Lenses To Reduce The Progression Of Myopia (QUR): 5 FDA-registered makers in 2 countries
5 establishments in 2 countries are registered with the FDA to make Prescription Spectacle Lenses To Reduce The Progression Of Myopia (product code QUR, Class 2, 21 CFR 886.5845). 5 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on September 25, 2025, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.
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- Product code
- QUR
- Device class
- 2
- Regulation
- 886.5845
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
Makers of Prescription Spectacle Lenses To Reduce The Progression Of Myopia
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Essilor Of America, Inc. | Dallas, TX, United States | Specification developer | 1 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Essilor Laboratories of America, Inc, dba Bell Optical Lab | Groveport, OH, United States | Manufacturer | 1 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Essilor Laboratories of America, Inc. dba Omega Northcreek Lab | Dallas, TX, United States | Manufacturer | 1 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Gentex Optics, Inc. | Dudley, MA, United States | Manufacturer | 1 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sofi De Chihuahua | 10 Y 11, Chihuahua, Chib, Mexico | Manufacturer | 1 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
Updated September 25, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.