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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 K101147
Device Name MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
Applicant
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Applicant Contact TATIANA EPSTEIN
Correspondent
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Correspondent Contact TATIANA EPSTEIN
Regulation Number878.4810
Classification Product Code
NUV  
Subsequent Product Codes
GEI   ISA  
Date Received04/23/2010
Decision Date 01/21/2011
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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