FDA.reportPublic FDA data

510(k) K223763

Device
ZeptoLink IOL Positioning System
Applicant
Centricity Vision, Inc.
510(k) number
K223763
Product code
PUL
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-11
Date received
2022-12-15
Regulation
886.4100
Classification name
Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Neal Hartman
Address
1939 Palomar Oaks Way, Suite A Carlsbad CA US 92011 92011

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PUL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221188ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.2022-06-23
K210827ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.2021-12-14
K170655ZeptoMynosys Cellular Devices, Inc.2017-06-02