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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Folders And Injectors, Intraocular Lens (Iol)
510(k) Number K252540
Device Name ACCUJECT Injector Set 2.1-1P (LP604590)
Applicant
Medicel AG
Dornierstrasse 11
Altenrhein,  CH 9423
Applicant Contact Erik Braziulis
Correspondent
Medicel AG
Dornierstrasse 11
Altenrhein,  CH 9423
Correspondent Contact Erik Braziulis
Regulation Number886.4300
Classification Product Code
MSS  
Date Received08/12/2025
Decision Date 09/16/2025
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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