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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 K140631
Device Name LUMENA FH HAIR REMOVAL SYSTEM
Applicant
SHASER, INC.
10 Maguire Rd Ste 120
Lexington,  MA  02421
Applicant Contact ANTHONY BURNS
Correspondent
SHASER, INC.
10 Maguire Rd Ste 120
Lexington,  MA  02421
Correspondent Contact ANTHONY BURNS
Regulation Number878.4810
Classification Product Code
ONF  
Date Received03/12/2014
Decision Date 05/16/2014
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
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