FDA Registration
Active
🇺🇸 United States
Alcon Research, LLC
Reg #: 2028159
·
FEI: 1000125771
·
Expires 2026
Products
19
Proprietary Names
0
Establishment Types
3
Classifications
19
Registration Details
- Registration Name
- Alcon Research, LLC
- Registration Number
- 2028159
- FEI Number
- 1000125771
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 15800 Alton Pkwy
- City
- IRVINE
- State
- CA
- ZIP
- 92618
- Country
- US
Regulatory Submissions
- 510(k) Number
- K890509
- PMA Number
- P230012
Owner / Operator
- Firm Name
- Alcon Laboratories, Inc.
- Operator Number
- 1610287
- Address
- 6201 South Freeway
- City
- Fort Worth
- State
- TX
- Postal Code
- 76134
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Laser, Ophthalmic | HQF | Class 2 | Ophthalmic | No | 2008-12-04 |
| 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 |
| 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 |
| Specula, Ophthalmic | HNC | Class 1 | Ophthalmic | No | 1977-12-30 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | Class 1 | General, Plastic Surgery | No | 1994-02-03 |
| Gases Used Within Eye To Place Pressure On Detached Retina | LPO | Class 3 | Ophthalmic | No | 2024-09-24 |
| Lens, Guide, Intraocular | KYB | Class 1 | Ophthalmic | No | 2012-04-19 |
| Eyelid Thermal Pulsation System | ORZ | Class 2 | Ophthalmic | No | 2019-02-08 |
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2021-01-04 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2021-01-04 |
| Stand, Instrument, Ac-Powered, Ophthalmic | HMF | Class 1 | Ophthalmic | No | 2024-02-05 |
| Aberrometer, Ophthalmic | NCF | Class 1 | Ophthalmic | No | 2004-02-03 |
| Camera, Cine, Microsurgical, Without Audio | FWJ | Class 1 | General, Plastic Surgery | No | 2016-08-29 |
| Microscope, Surgical | EPT | Class 1 | General, Plastic Surgery | No | 2016-08-30 |
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)