K261312
- 510(k) number
- K261312
- Device name
- Temporary Keratoprosthesis (QuickSet TKP)
- Applicant
- Eyekon Medical, Inc. FL · US
- Product code
- MLP — Keratoprosthesis, Temporary Implant, Surgical Use
- Decision date
- 2026-07-24
- Date received
- 2026-04-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ophthalmic
510(k) Summary (official FDA PDF): K261312.pdf
Official FDA record: K261312
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.