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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 K072564
Device Name ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM
Applicant
Alma Lasers , Ltd.
3637 Bernal Ave.
Pleasanton,  CA  94566
Applicant Contact ANNE WORDEN
Correspondent
Alma Lasers , Ltd.
3637 Bernal Ave.
Pleasanton,  CA  94566
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
FTC   HHR   LNK  
Date Received09/11/2007
Decision Date 05/23/2008
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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