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

K-Number: K170655 · 2017-06-02

ApplicantMynosys Cellular Devices, Inc.
Decision Date2017-06-02
Product CodePUL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Zepto is a medical device manufactured by Mynosys Cellular Devices, Inc.. It received FDA 510(k) clearance on 2017-06-02 under approval number K170655. 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?

Zepto is a medical device that received FDA 510(k) clearance on 2017-06-02. It is manufactured by Mynosys Cellular Devices, Inc.. The 510(k) number is K170655.

When was Zepto approved by the FDA?

Zepto received FDA 510(k) clearance on 2017-06-02, under approval number K170655.

What company makes Zepto?

Zepto is manufactured by Mynosys Cellular Devices, Inc..

What is the FDA product code for Zepto?

The FDA product code for Zepto is PUL.

Related Devices (Code: PUL)

K210827ZEPTO Precision Capsulotomy SystemCentricity Vision, 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.

↑