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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K113151
Device Name IFS LASER SYSTEM
Applicant
Abbott Medical Optics, Inc.
1700 E. Saint Andrew Pl.
Santa Ana,  CA  92705
Applicant Contact KESLEY E GALLAGHER
Correspondent
Abbott Medical Optics, Inc.
1700 E. Saint Andrew Pl.
Santa Ana,  CA  92705
Correspondent Contact KESLEY E GALLAGHER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received10/25/2011
Decision Date 03/08/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01210820
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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