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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratoprosthesis, Temporary Implant, Surgical Use
510(k) Number K261312
Device Name Temporary Keratoprosthesis (QuickSet TKP™)
Applicant
Eyekon Medical, Inc.
2451 Enterprise Rd.
Clearwater,  FL  33763
Applicant Contact Mark Robinson
Correspondent
Onera, LLC
2043 Evanston Cir.
Corona,  CA  92881
Correspondent Contact Robert Lundberg
Regulation Number886.3400
Classification Product Code
MLP  
Date Received04/21/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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