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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 K081704
Device Name SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
Applicant
Lumenis, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Applicant Contact TINA MAYER
Correspondent
Lumenis, Inc.
3959 W. 1820 S.
Salt Lake City,  UT  84104
Correspondent Contact TINA MAYER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HQF  
Date Received06/17/2008
Decision Date 09/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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