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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 K130015
Device Name SHASER V-MINI HAIR REMOVAL SYSTEM
Applicant
SHASER, INC.
10 MAGUIRE RD STE 120
BUILDING ONE
LEXINGTON,  MA  02421
Applicant Contact SARAH HACKETT
Correspondent
SHASER, INC.
10 MAGUIRE RD STE 120
BUILDING ONE
LEXINGTON,  MA  02421
Correspondent Contact SARAH HACKETT
Regulation Number878.4810
Classification Product Code
ONF  
Date Received01/03/2013
Decision Date 06/13/2013
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
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