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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 K133201
Device Name SHASER V-MINI 2 HAIR REMOVAL SYSTEM
Applicant
Shaser, Inc.
10 Maguire Rd.
Bldg. One
Lexington,  MA  02421
Applicant Contact ANTHONY BURNS
Correspondent
Shaser, Inc.
10 Maguire Rd.
Bldg. One
Lexington,  MA  02421
Correspondent Contact ANTHONY BURNS
Regulation Number878.4810
Classification Product Code
ONF  
Date Received10/17/2013
Decision Date 02/12/2014
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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