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FDA 510(k) Application Details - K223763
Device Classification Name
More FDA Info for this Device
510(K) Number
K223763
Device Name
ZeptoLink IOL Positioning System
Applicant
Centricity Vision, Inc.
1939 Palomar Oaks Way, Suite A
Carlsbad, CA 92011 US
Other 510(k) Applications for this Company
Contact
Neal Hartman
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PUL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/15/2022
Decision Date
04/11/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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