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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 K031960
Device Name INTRALASE FS LASER
Applicant
INTRALASE CORP.
9701 JERONIMO ROAD
IRVINE,  CA  92618
Applicant Contact CHARLINE GAUTHIER
Correspondent
INTRALASE CORP.
9701 JERONIMO ROAD
IRVINE,  CA  92618
Correspondent Contact CHARLINE GAUTHIER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received06/25/2003
Decision Date 09/29/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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