Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZEPTO Precision Capsulotomy System

K-Number: K221188 · 2022-06-23

ApplicantCentricity Vision, Inc.
Decision Date2022-06-23
Product CodePUL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ZEPTO Precision Capsulotomy 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 2022-06-23 under 510(k) number K221188. 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 2022-06-23. The listed applicant is Centricity Vision, Inc.. The 510(k) number is K221188.

When did ZEPTO Precision Capsulotomy System receive FDA 510(k) clearance?

ZEPTO Precision Capsulotomy System received FDA 510(k) clearance on 2022-06-23, under 510(k) number K221188.

Who is the listed applicant for ZEPTO Precision Capsulotomy 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 ZEPTO Precision Capsulotomy System?

The FDA product code for ZEPTO Precision Capsulotomy 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.

K223763ZeptoLink IOL Positioning 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.

K223763ZeptoLink IOL Positioning 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.

↑