FDA Registration
Active
🇺🇸 United States
ESSILOR OF AMERICA, INC.
Reg #: 1624788
·
FEI: 1000058437
·
Expires 2026
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ESSILOR OF AMERICA, INC.
- Registration Number
- 1624788
- FEI Number
- 1000058437
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 13555 N Stemmons Fwy
- City
- DALLAS
- State
- TX
- ZIP
- 75234
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN250016
Owner / Operator
- Firm Name
- Essilor of America, Inc
- Operator Number
- 8010073
- Address
- 13515 N Stemmons Fwy
- City
- Dallas
- State
- TX
- Postal Code
- 75234
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prescription Spectacle Lenses To Reduce The Progression Of Myopia | QUR | Class 2 | Ophthalmic | No | 2025-09-26 |
Proprietary Names
Essilor Stellest, Essilor Stellest Glasses
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility