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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 K103495
Device Name ASICO SOFTIP INJECTOR SYSTEM
Applicant
Asico, LLC
26 Plz. Dr.
Westmont,  IL  60559
Applicant Contact RAVI NALLAKRISHNAN
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact CASEY CONRY
Regulation Number886.4300
Classification Product Code
MSS  
Date Received11/29/2010
Decision Date 06/29/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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