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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 K082809
Device Name ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM
Applicant
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact FRANCES E HARRISON
Correspondent
LUMENIS, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact FRANCES E HARRISON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/24/2008
Decision Date 12/18/2008
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
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