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FDA 510(k)

ZeptoLink IOL Positioning System

K-Number: K223763 · 2023-04-11

ApplicantCentricity Vision, Inc.
Decision Date2023-04-11
Product CodePUL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZeptoLink IOL Positioning System is the device name listed in this FDA 510(k) record. The listed applicant is Centricity Vision, Inc.. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K223763. The device is classified under product code PUL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZeptoLink IOL Positioning System?

ZeptoLink IOL Positioning System is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Centricity Vision, Inc.. The 510(k) number is K223763.

When did ZeptoLink IOL Positioning System receive FDA 510(k) clearance?

ZeptoLink IOL Positioning System received FDA 510(k) clearance on 2023-04-11, under 510(k) number K223763.

Who is the listed applicant for ZeptoLink IOL Positioning System?

The FDA 510(k) record lists Centricity Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZeptoLink IOL Positioning System?

The FDA product code for ZeptoLink IOL Positioning System is PUL.

Other records listing Centricity Vision, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221188ZEPTO Precision Capsulotomy SystemK210827ZEPTO Precision Capsulotomy System

Related Devices (Code: PUL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K221188ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.K210827ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.K170655ZeptoMynosys Cellular Devices, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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