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FDA 510(k) Application Details - K222352
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K222352
Device Name
Powered Laser Surgical Instrument
Applicant
D.E.A Project S.r.1.
Via Italia, 16/interno A1
Mapello 24030 IT
Other 510(k) Applications for this Company
Contact
Nico Guerini
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
08/04/2022
Decision Date
04/27/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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