Temporary Keratoprosthesis (QuickSet TKP)— 510(k) K261312

Name: FDA 510(k) clearance K261312
Creator: U.S. Food and Drug Administration
Published: 2026-07-24

Substantially Equivalent

Eyekon Medical, Inc.

FDA 510(k) clearance K261312 for Temporary Keratoprosthesis (QuickSet TKP), Substantially Equivalent on 2026-07-24. Applicant: Eyekon Medical, Inc.. Device class: 2.

Summary

Eyekon Medical's Temporary Keratoprosthesis (QuickSet TKP) is filed under MLP, temporary keratoprosthesis implants for surgical use. The record doesn't give sizes or materials.

Class II, 21 CFR 886.3400. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Eyekon Medical filed from Clearwater, Florida. Review took 94 calendar days (April 21 to July 24, 2026).

Clearance details

Applicant: Eyekon Medical, Inc.
Product code: Product code MLP
Device class: Class 2
Regulation: 21 CFR 886.3400
Advisory panel: Ophthalmic
Date received: 2026-04-21
Decision date: 2026-07-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.