FDA Registration
Active
🇩🇪 Germany
WAVELIGHT GmbH
Reg #: 3003288808
·
FEI: 3003288808
·
Expires 2026
Products
7
Proprietary Names
0
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- WAVELIGHT GmbH
- Registration Number
- 3003288808
- FEI Number
- 3003288808
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Industriegebiet Doellnitz 5
- City
- PRESSATH Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K141476
- PMA Number
- P020050
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 |
|---|---|---|---|---|---|
| Topographer, Corneal, Ac-Powered | MMQ | Class 1 | Ophthalmic | No | 2023-11-09 |
| Aberrometer, Ophthalmic | NCF | Class 1 | Ophthalmic | No | 2004-02-03 |
| Excimer Laser System | LZS | Class 3 | Unknown | No | 2023-11-09 |
| Table, Instrument, Powered, Ophthalmic | HRJ | Class 1 | Ophthalmic | No | 2023-11-09 |
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2023-11-09 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-11-09 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2023-11-09 |
Establishment Types
Manufacture Medical Device