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FDA 510(k)

ZEPTO Precision Capsulotomy System

K-Number: K210827 · 2021-12-14

ApplicantCentricity Vision, Inc.
Decision Date2021-12-14
Product CodePUL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZEPTO Precision Capsulotomy System is a medical device manufactured by Centricity Vision, Inc.. It received FDA 510(k) clearance on 2021-12-14 under approval number K210827. 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 ZEPTO Precision Capsulotomy System?

ZEPTO Precision Capsulotomy System is a medical device that received FDA 510(k) clearance on 2021-12-14. It is manufactured by Centricity Vision, Inc.. The 510(k) number is K210827.

When was ZEPTO Precision Capsulotomy System approved by the FDA?

ZEPTO Precision Capsulotomy System received FDA 510(k) clearance on 2021-12-14, under approval number K210827.

What company makes ZEPTO Precision Capsulotomy System?

ZEPTO Precision Capsulotomy System is manufactured by Centricity Vision, Inc..

What is the FDA product code for ZEPTO Precision Capsulotomy System?

The FDA product code for ZEPTO Precision Capsulotomy System is PUL.

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Other Devices by Centricity Vision, Inc.

K221188ZEPTO Precision Capsulotomy System K223763ZeptoLink IOL Positioning System

Related Devices (Code: PUL)

K170655ZeptoMynosys Cellular Devices, Inc. K221188ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc. K223763ZeptoLink IOL Positioning SystemCentricity Vision, 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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