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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Graft Insertion Instrument For Endothelial Keratoplasty
510(k) Number K203586
Device Name EndoSerter-PL
Applicant
Corneagen, Inc.
101 N. Chestnut St.
Suite 303
Winston-Salem,  NC  27101
Applicant Contact Tom Miller
Correspondent
K.Hodai Consulting, Inc.
23 Bellflower
Lake Forest,  CA  92630
Correspondent Contact Omid Kodai
Regulation Number886.4300
Classification Product Code
OTZ  
Date Received12/08/2020
Decision Date 02/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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