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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 K001211
Device Name MODIFICATION TO INTRALASE 600C LASER KERATOME
Applicant
Intra Lase Corp.
9701 Jeronimo Rd.
Irvine,  CA  92618
Applicant Contact CHARLINE GAUTHIER
Correspondent
Intra Lase Corp.
9701 Jeronimo Rd.
Irvine,  CA  92618
Correspondent Contact CHARLINE GAUTHIER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received04/14/2000
Decision Date 12/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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