Data / Medical devices / United States / Essilor Laboratories of America, Inc. dba Omega Northcreek Lab
Essilor Laboratories of America, Inc. dba Omega Northcreek Lab: FDA-registered device maker in Dallas, TX, United States, 1 510(k) clearance
Essilor Laboratories of America, Inc. dba Omega Northcreek Lab is registered with the FDA (registration 3038269608) in Dallas, TX, United States. It lists 2 device types. 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
- 3038269608
- Address
- 13675 N Stemmons Fwy, Dallas, TX, United States, 75234
- Owner or operator
- Essilor of America, Inc (8010073)
- Roles
- Manufacturer
- First device listed
- April 30, 2009
- Registered through
- 2026
- Brand names listed
- Essilor Stellest, Essilor Stellest Glasses, Essilor Stellest Miraflex, Presio i Approval
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | 1 | Manufacturer | accessdata.fda.gov |
| Prescription Spectacle Lenses To Reduce The Progression Of Myopia | QUR | 2 | Manufacturer | 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
- All makers of Lens, Spectacle (Prescription), For Reading Discomfort
- All makers of Prescription Spectacle Lenses To Reduce The Progression Of Myopia
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.