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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 the device name listed in this FDA 510(k) record. The listed applicant is Mynosys Cellular Devices, Inc.. It received FDA 510(k) clearance on 2017-06-02 under 510(k) 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. The listed applicant is Mynosys Cellular Devices, Inc.. The 510(k) number is K170655.

When did Zepto receive FDA 510(k) clearance?

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

Who is the listed applicant for Zepto?

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

What is the FDA product code for Zepto?

The FDA product code for Zepto is PUL.

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.K221188ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.K210827ZEPTO Precision Capsulotomy 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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