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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K103560
Device Name SHASER IPL HAIR REMOVAL SYSTEM
Applicant
Shaser, Inc.
32 Harrison St.
Melrose,  MA  02176
Applicant Contact GLEN EMELOCK
Correspondent
Shaser, Inc.
32 Harrison St.
Melrose,  MA  02176
Correspondent Contact GLEN EMELOCK
Regulation Number878.4810
Classification Product Code
ONF  
Date Received12/03/2010
Decision Date 05/18/2011
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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