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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 K120080
Device Name SHASER HRS2 HAIR REMOVAL SYSTEM
Original Applicant
SHASER, INC.
32 harrison st.
melrose,  MA  02176
Original Contact glen emelock
Regulation Number878.4810
Classification Product Code
ONF  
Date Received01/11/2012
Decision Date 05/25/2012
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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