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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Light Induced Heating
510(k) Number K082622
Device Name ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE
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
NUV  
Subsequent Product Codes
GEI   ISA  
Date Received09/09/2008
Decision Date 01/12/2009
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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