FDA Registration
Active
🇧🇪 Belgium
Alcon Laboratories Belgium
Reg #: 3015456951
·
FEI: 3015456951
·
Expires 2026
Products
21
Proprietary Names
0
Establishment Types
1
Classifications
21
Registration Details
- Registration Name
- Alcon Laboratories Belgium
- Registration Number
- 3015456951
- FEI Number
- 3015456951
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Lichterveld 3
- City
- Puurs-Sint-Amands Antwerpen
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K110951
- PMA Number
- P930014
Owner / Operator
- Firm Name
- Alcon Laboratories, Inc.
- Operator Number
- 1610287
- Address
- 6201 South Freeway
- City
- Fort Worth
- State
- TX
- Postal Code
- 76134
- Country
- US
US Agent
- Business Name
- ALCON LABORATORIES, INC.
- Contact Name
- Dale Schaper
- Address
- 6201 SOUTH FREEWAY
- City
- Fort Worth
- State
- TX
- ZIP
- 76134
- Country
- US
- [email protected]
- Phone
- 817 5686421
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Extended Depth Of Focus Intraocular Lens | POE | Class 3 | Ophthalmic | No | 2007-11-21 |
| Lens, Multifocal Intraocular | MFK | Class 3 | Ophthalmic | No | 2007-11-21 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2007-11-21 |
| Lens, Intraocular, Toric Optics | MJP | Class 3 | Ophthalmic | No | 2007-11-21 |
| Aid, Surgical, Viscoelastic | LZP | Class 3 | Ophthalmic | No | 2014-10-15 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2012-04-19 |
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2012-04-19 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2012-04-19 |
| Cannula, Trocar, Ophthalmic | NGY | Class 1 | Ophthalmic | No | 2012-04-19 |
| Scissors, Ophthalmic | HNF | Class 1 | Ophthalmic | No | 1977-12-30 |
| Ring, Endocapsular | MRJ | Class 3 | Unknown | No | 2014-06-16 |
| Spatula, Ophthalmic | HND | Class 1 | Ophthalmic | No | 1977-12-30 |
| Lens, Fundus, Hruby, Diagnostic | HJI | Class 1 | Ophthalmic | No | 2017-09-27 |
| Clip, Iris Retractor | HOC | Class 1 | Ophthalmic | No | 2017-09-27 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 1977-12-30 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2007-12-13 |
| Vitrectomy, Instrument Cutter | MLZ | Class 2 | Ophthalmic | No | 2007-12-13 |
| Apparatus, Cautery, Radiofrequency, Ac-Powered | HQR | Class 2 | Ophthalmic | No | 2007-12-13 |
| Knife, Ophthalmic | HNN | Class 1 | Ophthalmic | No | 1994-02-03 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2002-04-15 |
| Implant, Eye Valve | KYF | Class 2 | Ophthalmic | No | 2010-03-02 |
Establishment Types
Export Device to the United States But Perform No Other Operation on Device