FDA Registration
Active
🇺🇸 United States
CooperVision, Inc.
Reg #: 3011771819
·
FEI: 3011771819
·
Expires 2026
Products
5
Proprietary Names
22
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- CooperVision, Inc.
- Registration Number
- 3011771819
- FEI Number
- 3011771819
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 209 High Point, Suite 100
- City
- Victor
- State
- NY
- ZIP
- 14564
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181920
- PMA Number
- P850079
Owner / Operator
- Firm Name
- COOPERVISION, INC.
- Operator Number
- 9929062
- Address
- 6101 Bollinger Canyon Road, Suite 500
- City
- San Ramon
- State
- CA
- Postal Code
- 94583
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | Class 2 | Ophthalmic | No | 2019-01-18 |
| Lenses, Soft Contact, Daily Wear | LPL | Class 2 | Ophthalmic | No | 2019-01-18 |
| Lenses, Soft Contact, Extended Wear | LPM | Class 3 | Ophthalmic | No | 2006-04-27 |
| Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | QIT | Class 3 | Unknown | No | 2019-11-18 |
| Accessories, Soft Lens Products | LPN | Class 2 | Ophthalmic | No | 2014-11-03 |
Proprietary Names
Clariti 1 Day
Clariti 1 Day Multifocal
Clariti 1 Day Toric
HYDRASOFT XW STANDARD (sphere)
HYDRASOFT TORIC XW
iWear Active
Avaira Vitality Toric
Avaira Vitality Sphere
Softmed Breathables Advanced Toric
Pearle Vision 1-day Premium Multifocal
MyDay Energys
MyDay Multifocal
MyDay Toric
MyDay Asphere
BIOFINITY XR
BIOFINITY MULTIFOCAL
BIOFINITY TORIC
Biofinity
Biofinity Energys
Biofinity XR Toric
Biofinity XR Multifocal
BIOFINITY TORIC MULTIFOCAL
Establishment Types
Complaint File Establishment per 21 CFR 820.198