Data / Medical devices / United States / Eyekon Medical, Inc.
Eyekon Medical, Inc.: FDA-registered device maker in Clearwater, FL, United States, 1 510(k) clearance and 1 PMA approval
Eyekon Medical, Inc. is registered with the FDA (registration 1038833) in Clearwater, FL, United States. It lists 6 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated July 24, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1038833
- Address
- 2451 Enterprise Rd, Clearwater, FL, United States, 33763
- Owner or operator
- EYEKON MEDICAL, INC. (1038833)
- Roles
- Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler
- First device listed
- December 5, 2007
- Registered through
- 2026
- Brand names listed
- Acuity, Acurus, CTR-10, CTR-10 Blue, CTR-12, CTR-12 Blue, Cirrus, DGR and more
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 | Repackager or relabeler | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Contract manufacturer, Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Keratoprosthesis, Temporary Implant, Surgical Use | MLP | 2 | Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | Manufacturer for export | accessdata.fda.gov |
| Ring, Endocapsular | MRJ | 3 | Manufacturer for export | 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 |
|---|---|---|---|---|---|---|
| July 24, 2026 | K261312 | Temporary Keratoprosthesis (QuickSet TKP) | MLP | Substantially Equivalent | Eyekon Medical, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| September 22, 1989 | P880072 | MODEL P11 MODIFIED J LOOP POSTERIOR CHAMBER IOL | HQL | 31 | June 20, 2000 | accessdata.fda.gov |
Compare with other makers
- All makers of Folders And Injectors, Intraocular Lens (Iol)
- All makers of Aid, Surgical, Viscoelastic
- All makers of Intraocular Lens
- All makers of Ring, Endocapsular
- All makers of Lens, Multifocal Intraocular
Updated July 24, 2026. 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.