Data / Medical devices / United States / Essilor Of America, Inc.
Essilor Of America, Inc.: FDA-registered device maker in Dallas, TX, United States, 1 510(k) clearance
Essilor Of America, Inc. is registered with the FDA (registration 1624788) in Dallas, TX, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 25, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 1624788
- FEI number
- 1000058437
- Address
- 13555 N Stemmons Fwy, Dallas, TX, United States, 75234
- Owner or operator
- Essilor of America, Inc (8010073)
- Roles
- Specification developer
- First device listed
- September 26, 2025
- Registered through
- 2026
- Brand names listed
- Essilor Stellest, Essilor Stellest Glasses, Essilor Stellest Miraflex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prescription Spectacle Lenses To Reduce The Progression Of Myopia | QUR | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 25, 2025 | DEN250016 | Essilor® Stellest® | QUR | Unknown | Essilor Of America, Inc. | accessdata.fda.gov |
Compare with other makers
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.