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FDA 510(k) Application Details - K133238
Device Classification Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
More FDA Info for this Device
510(K) Number
K133238
Device Name
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
Applicant
SYNERON MEDICAL LTD
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA, PA 19103 US
Other 510(k) Applications for this Company
Contact
JANICE M HOGAN
Other 510(k) Applications for this Contact
Regulation Number
878.4590
More FDA Info for this Regulation Number
Classification Product Code
OHV
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/21/2013
Decision Date
04/10/2014
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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