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FDA 510(k) Application Details - K222933
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K222933
Device Name
Device,Analysis,Anterior Segment
Applicant
VISIA Imaging S.r.l.
Via Martiri della Libertα 95/e
San Giovanni Valdarno 52027 IT
Other 510(k) Applications for this Company
Contact
Alessia Magnanini
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/26/2022
Decision Date
06/29/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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