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FDA 510(k) Application Details - K193500
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K193500
Device Name
Powered Laser Surgical Instrument
Applicant
Lumenis Ltd.
6 Hakidma Street PO Box 240
Yokneam 2069204 IL
Other 510(k) Applications for this Company
Contact
Shlomit Segman
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
12/17/2019
Decision Date
01/16/2020
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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