FDA Registration
Active
🇺🇸 United States
AMO Manufacturing USA, LLC
Reg #: 3006695864
·
FEI: 3006695864
·
Expires 2026
Products
5
Proprietary Names
10
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- AMO Manufacturing USA, LLC
- Registration Number
- 3006695864
- FEI Number
- 3006695864
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 510 Cottonwood Drive
- City
- Milpitas
- State
- CA
- ZIP
- 95035
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203060
- PMA Number
- P930016
Owner / Operator
- Firm Name
- Johnson & Johnson Surgical Vision, Inc.
- Operator Number
- 10053607
- Address
- 31 Technology Dr., Suite 200
- City
- Irvine
- State
- CA
- Postal Code
- 92618
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2021-03-15 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2016-12-22 |
| Keratome, Ac-Powered | HNO | Class 1 | Ophthalmic | No | 2016-12-22 |
| Ophthalmic Femtosecond Laser | OOE | Class 2 | Ophthalmic | No | 2019-06-26 |
| Excimer Laser System | LZS | Class 3 | Unknown | No | 2016-12-22 |
Proprietary Names
Keratome, ac-powered
Powered laser surgical instrument
Unit, phacofragmentation
Gen3 LOI
ELITA Femtosecond Laser System
ELITA Patient Interface 1-pack
ELITA Patient Interface 20-pack
Excimer laser system
Ophthalmic femtosecond laser
Ophthalmic Femtosecond Laser
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device