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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 K100228
Device Name VERSAPULSE MODEL P20 LASER SYSTEM
Applicant
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact DOUG STANTE
Correspondent
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact DOUG STANTE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/26/2010
Decision Date 02/24/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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