FDA Registration
Active
🇫🇷 France
ESSILOR INTERNATIONAL
Reg #: 3003325113
·
FEI: 3003325113
·
Expires 2026
Products
5
Proprietary Names
21
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- ESSILOR INTERNATIONAL
- Registration Number
- 3003325113
- FEI Number
- 3003325113
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 81 BLD J-B OUDRY
- City
- CRETEIL Val-de-Marne
- Country
- FR
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
US Agent
- Business Name
- EssilorLuxottica
- Contact Name
- M Shannon McMurrey
- Address
- 13555 N Stemmons Fwy
- City
- Dallas
- State
- TX
- ZIP
- 75234
- Country
- US
- [email protected]
- Phone
- 972 8005206
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Spectacle, Non-Custom (Prescription) | HQG | Class 1 | Ophthalmic | No | 2006-12-01 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 1977-12-19 |
| Lens, Spectacle (Prescription), For Reading Discomfort | NJH | Class 1 | Ophthalmic | No | 2009-04-30 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2006-12-01 |
| Digital Visual Acuity Test | QTO | Class 1 | Ophthalmic | No | 2022-09-26 |
Proprietary Names
Small Fit
Ovation
Varilux
Xperio
Trivex
Presio i Approval
Kodak
Avance
TruClear
DEFINITY 2
Definity
VARILUX-2
Crizal
Sharpview
Essilor Ideal
Optifog
Essilor
Luxottica
Crizal Sun
My Vision Check
Online Vision Test
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device