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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 K060372
Device Name INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
Applicant
Intra Lase Corp.
9701 Jeronimo Rd.
Irvine,  CA  92618 -1916
Applicant Contact CHARLINE GAUTHIER
Correspondent
Johnson & Johnson Surgical Vision, Inc.
31 Technology Dr. Suite 200
Irvine,  CA  92618
Correspondent Contact CHARLINE GAUTHIER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received02/13/2006
Decision Date 08/16/2006
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
Predetermined Change
Control Plan Authorized		 No
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