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FDA 510(k) Application Details - K143339
Device Classification Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
More FDA Info for this Device
510(K) Number
K143339
Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Applicant
ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.)
KOCHAV YOKNEAM BLDG. YOKNEAM INDUSTRIAL ZONE
YOKNEAM ILLIT 20692 IL
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BOBAE KIM
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
ONF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2014
Decision Date
12/19/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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