FDA Registration
Active
🇺🇸 United States
EYEKON MEDICAL, INC.
Reg #: 1038833
·
FEI: 1038833
·
Expires 2026
Products
5
Proprietary Names
15
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- EYEKON MEDICAL, INC.
- Registration Number
- 1038833
- FEI Number
- 1038833
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2451 Enterprise Rd
- City
- CLEARWATER
- State
- FL
- ZIP
- 33763
- Country
- US
Regulatory Submissions
- PMA Number
- P880072
Owner / Operator
- Firm Name
- EYEKON MEDICAL, INC.
- Operator Number
- 1038833
- Address
- 2451 ENTERPRISE RD.
- City
- Clearwater
- State
- FL
- Postal Code
- 33763
- Country
- US
- Correspondent
- Mark Robinson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ring, Endocapsular | MRJ | Class 3 | Unknown | No | 2010-07-09 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2016-02-01 |
| Lens, Multifocal Intraocular | MFK | Class 3 | Ophthalmic | No | 2007-12-05 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2007-12-05 |
| Aid, Surgical, Viscoelastic | LZP | Class 3 | Ophthalmic | No | 2007-12-05 |
Proprietary Names
CTR-12 Blue
CTR-10
CTR-10 Blue
CTR-12
EyeKon 1 Injector
EyeKon-2.2 IOL Injector
Acuity
MTH
Isotechnics
Suncoast
EyeKon
MDR
DGR
Cirrus
Acurus
Establishment Types
Manufacture Device in the United States for Export Only
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device