FDA.reportPublic FDA data

510(k) K210827

Device
ZEPTO Precision Capsulotomy System
Applicant
Centricity Vision, Inc.
510(k) number
K210827
Product code
PUL
Decision
Substantially Equivalent (SESE)
Decision date
2021-12-14
Date received
2021-03-19
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
K223763ZeptoLink IOL Positioning SystemCentricity Vision, Inc.2023-04-11
K221188ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.2022-06-23
K170655ZeptoMynosys Cellular Devices, Inc.2017-06-02