FDA Registration
Active
🇺🇸 United States
ICU Eyecare Solutions Inc.
Reg #: 2936829
·
FEI: 2936829
·
Expires 2026
Products
6
Proprietary Names
5
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- ICU Eyecare Solutions Inc.
- Registration Number
- 2936829
- FEI Number
- 2936829
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1900 Shelton Dr
- City
- HOLLISTER
- State
- CA
- ZIP
- 95023
- Country
- US
Regulatory Submissions
- 510(k) Number
- K991206
Owner / Operator
- Firm Name
- ICU Eyecare Solutions Inc.
- Operator Number
- 10091386
- Address
- 1900 Shelton Drive
- City
- Hollister
- State
- CA
- Postal Code
- 95023
- Country
- US
- Correspondent
- Hemalee Govind
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mask, Scavenging | KHA | Class 1 | Anesthesiology | No | 2024-09-13 |
| Case, Contact Lens | LRX | Class 2 | Ophthalmic | No | 2025-01-03 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | Class 1 | Ophthalmic | No | 2024-09-13 |
| Spectacle, Magnifying | HOI | Class 1 | Ophthalmic | No | 2024-09-13 |
| System, Reading, Television, Closed-Circuit | HJG | Class 1 | Ophthalmic | No | 2024-09-13 |
| Magnifier, Hand-Held, Low-Vision | HJF | Class 1 | Ophthalmic | No | 2024-09-13 |
Proprietary Names
Mask
Sunglasses
Eyecare
Reading
Magnifying
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility