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FDA 510(k) Application Details - K173169
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K173169
Device Name
Powered Laser Surgical Instrument
Applicant
SharpLight Technologies Ltd.
33 Lazarov St.
Rishon Le Zion 7565435 IL
Other 510(k) Applications for this Company
Contact
Ilan Sharon
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
09/29/2017
Decision Date
11/20/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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