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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 K112031
Device Name ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION
Applicant
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Applicant Contact ANNE WORDEN
Correspondent
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/15/2011
Decision Date 09/13/2011
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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