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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 K073404
Device Name IFS LASER SYSTEM
Applicant
Intra Lase Corp.
5 Grindlay Pl.
Aliso Viejo,  CA  92656
Applicant Contact MAUREEN WEINER
Correspondent
Johnson & Johnson Surgical Vision
31 Technology Dr., Suite 200
Irvine,  CA  92618
Correspondent Contact MAUREEN WEINER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HNO  
Date Received12/04/2007
Decision Date 04/25/2008
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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