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510(k) K221188

Device
ZEPTO Precision Capsulotomy System
Applicant
Centricity Vision, Inc.
510(k) number
K221188
Product code
PUL  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-23
Date received
2022-04-25
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
K210827ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.2021-12-14
K170655ZeptoMynosys Cellular Devices, Inc.2017-06-02

Legacy Summary#

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FDA Review#

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