FDA Registration
Active
🇺🇸 United States
U.S. IOL, INC.
Reg #: 1037089
·
FEI: 1037089
·
Expires 2026
Products
6
Proprietary Names
7
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- U.S. IOL, INC.
- Registration Number
- 1037089
- FEI Number
- 1037089
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2500 SANDERSVILLE RD.
- City
- LEXINGTON
- State
- KY
- ZIP
- 40511
- Country
- US
Regulatory Submissions
- 510(k) Number
- K024091
Owner / Operator
- Firm Name
- U.S. IOL, INC.
- Operator Number
- 1037089
- Address
- 2500 SANDERSVILLE RD., --
- City
- Lexington
- State
- KY
- Postal Code
- 40511
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Suture, Nonabsorbable, Silk | GAP | Class 2 | General, Plastic Surgery | No | 2016-06-07 |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | Class 1 | Ophthalmic | No | 2020-03-05 |
| Aid, Surgical, Viscoelastic | LZP | Class 3 | Ophthalmic | No | 2020-03-06 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | Class 2 | General, Plastic Surgery | No | 2016-06-07 |
| Intraocular Lens | HQL | Class 3 | Ophthalmic | No | 2008-01-28 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | Class 2 | General, Plastic Surgery | No | 2016-06-07 |
Proprietary Names
USIOL Silk Sutures
OCCULON HV
USIOL Nylon Sutures
Biocryl
USIOL PMMA Lens
USIOL PGA Sutures
Hydrophilic Acrylic IOLs 860UV and 867UV
Establishment Types
Repack or Relabel Medical Device
Manufacture Device in the United States for Export Only