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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 K151109
Device Name Lumenis Smart532 Laser System
Applicant
LUMENIS, INC.
1870 S MILESTONE DRIVE
SALT LAKE CITY,  UT  84101
Applicant Contact Jayce R. McLane
Correspondent
LUMENIS, INC.
1870 S MILESTONE DRIVE
SALT LAKE CITY,  UT  84101
Correspondent Contact Jace McLane
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/27/2015
Decision Date 10/30/2015
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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