FDA 510(k) Application Details - K101147

Device Classification Name Massager, Vacuum, Light Induced Heating

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510(K) Number K101147
Device Name Massager, Vacuum, Light Induced Heating
Applicant ALMA LASERS, INC.
485 HALF DAY RD.
SUITE #100
BUFFALO GROVE, IL 60089 US
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Contact TATIANA EPSTEIN
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Regulation Number 878.4810

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Classification Product Code NUV
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Date Received 04/23/2010
Decision Date 01/21/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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