Temporary Keratoprosthesis (QuickSet TKP™)
K-Number: K261312 · 2026-07-24
ApplicantEyekon Medical, Inc.
Decision Date2026-07-24
Product CodeMLP
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Temporary Keratoprosthesis (QuickSet TKP™) is the device name listed in this FDA 510(k) record. The listed applicant is Eyekon Medical, Inc.. It received FDA 510(k) clearance on 2026-07-24 under 510(k) number K261312. The device is classified under product code MLP. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Temporary Keratoprosthesis (QuickSet TKP™)?
Temporary Keratoprosthesis (QuickSet TKP™) is a medical device that received FDA 510(k) clearance on 2026-07-24. The listed applicant is Eyekon Medical, Inc.. The 510(k) number is K261312.
When did Temporary Keratoprosthesis (QuickSet TKP™) receive FDA 510(k) clearance?
Temporary Keratoprosthesis (QuickSet TKP™) received FDA 510(k) clearance on 2026-07-24, under 510(k) number K261312.
Who is the listed applicant for Temporary Keratoprosthesis (QuickSet TKP™)?
The FDA 510(k) record lists Eyekon Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Temporary Keratoprosthesis (QuickSet TKP™)?
The FDA product code for Temporary Keratoprosthesis (QuickSet TKP™) is MLP.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.