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FDA 510(k) Application Details - K162556
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K162556
Device Name
Powered Laser Surgical Instrument
Applicant
VITAGE LED LTD
THE PAVILLION, JOSSELIN ROAD
BASILDON SS131QB GB
Other 510(k) Applications for this Company
Contact
SUE D'ARCY
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/14/2016
Decision Date
03/24/2017
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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