Data / Medical devices / United States / U.S. Iol, Inc.
U.S. Iol, Inc.: FDA-registered device maker in Lexington, KY, United States, 3 510(k) clearances
U.S. Iol, Inc. is registered with the FDA (registration 1037089) in Lexington, KY, United States. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 15, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1037089
- Address
- 2500 Sandersville RD., Lexington, KY, United States, 40511
- Owner or operator
- U.S. IOL, INC. (1037089)
- Roles
- Manufacturer for export, Repackager or relabeler
- First device listed
- January 28, 2008
- Registered through
- 2026
- Brand names listed
- Biocryl, Hydrophilic Acrylic IOLs 860UV and 867UV, OCCULON HV, USIOL Nylon Sutures, USIOL PGA Sutures, USIOL PMMA Lens, USIOL Silk Sutures
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Surgical, Viscoelastic | LZP | 3 | Manufacturer for export | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Manufacturer for export | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer for export, Repackager or relabeler | accessdata.fda.gov |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Silk | GAP | 2 | Repackager or relabeler | accessdata.fda.gov |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 2 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2014 | K140039 | POLYCRYL | GAM | Substantially Equivalent | Aurolab | accessdata.fda.gov |
| February 28, 2003 | K024091 | SILK SUTURES | GAP | Substantially Equivalent | Aurolab | accessdata.fda.gov |
| February 28, 2003 | K024090 | NYLON SUTURE | GAR | Substantially Equivalent | Aurolab | accessdata.fda.gov |
Compare with other makers
- All makers of Suture, Absorbable, Synthetic, Polyglycolic Acid
- All makers of Folders And Injectors, Intraocular Lens (Iol)
- All makers of Suture, Nonabsorbable, Silk
- All makers of Intraocular Lens
- All makers of Aid, Surgical, Viscoelastic
- All makers of Suture, Nonabsorbable, Synthetic, Polyamide
Updated September 15, 2014. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.