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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K072699
Device Name ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL
Applicant
Alma Lasers , Ltd.
3637 Bernal Ave.
Pleasanton,  CA  94566
Applicant Contact A WORDEN
Correspondent
Alma Lasers , Ltd.
3637 Bernal Ave.
Pleasanton,  CA  94566
Correspondent Contact A WORDEN
Regulation Number878.4400
Classification Product Code
GEI  
Date Received09/24/2007
Decision Date 10/05/2007
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
Predetermined Change
Control Plan Authorized		 No
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