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FDA 510(k) Application Details - K122579
Device Classification Name
Massager, Vacuum, Light Induced Heating
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
SAM WADE
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
NUV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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