Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Centricity Vision, Inc.. It received FDA 510(k) clearance on 2022-06-23 under approval 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. It is manufactured by Centricity Vision, Inc.. The 510(k) number is K221188.

When was ZEPTO Precision Capsulotomy System approved by the FDA?

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

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.

Related Clinical Trials

NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT05554133 Precision Optical Guidance for Oral Biopsy RECRUITING NCT07296276 Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM RECRUITING NCT07516145 Robotic Transjugular Transcatheter Tricuspid Valve Replacement RECRUITING

Other Devices by Centricity Vision, Inc.

K210827ZEPTO Precision Capsulotomy System K223763ZeptoLink IOL Positioning System

Related Devices (Code: PUL)

K170655ZeptoMynosys Cellular Devices, Inc. K210827ZEPTO 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.

↑