FDA Registration
Active
🇺🇸 United States
FRESNEL PRISM & LENS CO.
Reg #: 2086350
·
FEI: 3003615773
·
Expires 2026
Products
5
Proprietary Names
7
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- FRESNEL PRISM & LENS CO.
- Registration Number
- 2086350
- FEI Number
- 3003615773
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 10810 NESBITT AVE S
- City
- Bloomington
- State
- MN
- ZIP
- 55437
- Country
- US
Owner / Operator
- Firm Name
- THE FRESNEL PRISM AND LENS COMPANY
- Operator Number
- 9032895
- Address
- 10810 Nesbitt Ave. S., --
- City
- Bloomington
- State
- MN
- Postal Code
- 55437
- Country
- US
- Correspondent
- Kathy J Armstrong
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | Class 1 | Ophthalmic | No | 2004-02-04 |
| Frame, Spectacle | HQZ | Class 1 | Ophthalmic | No | 2019-05-03 |
| Fixation, Vision Training, Binocular | NXR | Class 1 | Ophthalmic | No | 2019-05-03 |
| Prism, Fresnel, Ophthalmic | HKT | Class 1 | Ophthalmic | No | 2001-07-24 |
| Set, Lens, Trial, Ophthalmic | HPC | Class 1 | Ophthalmic | No | 2008-07-25 |
Proprietary Names
CoverClude Occlusion Eye Patch
Vision Screening Patch
MYI Occlusion Eye Patches
MIN Occlusion Lens
Bangerter Occlusion Foil Bar
D Segment of 3M Press On Fresnel Lens
Fresnel Prism Trial Sets
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device
Reprocess Single-Use Device