FDA 510(k) Application Details - K122579

Device Classification Name Massager, Vacuum, Light Induced Heating

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510(K) Number K122579
Device Name Massager, Vacuum, Light Induced Heating
Applicant SYNERON MEDICAL LTD.
INDUSTRIAL ZONE
TAVOR BLDG P.O.B 550
YOKNEAM, ILLIT 20692 IL
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Contact SAM WADE
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Regulation Number 878.4810

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Classification Product Code NUV
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Date Received 08/23/2012
Decision Date 09/13/2012
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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