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FDA 510(k)

Tixel System

K-Number: K202988 · 2021-02-25

ApplicantNovoxel , Ltd.
Decision Date2021-02-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tixel System is a medical device manufactured by Novoxel , Ltd.. It received FDA 510(k) clearance on 2021-02-25 under approval number K202988. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tixel System?

Tixel System is a medical device that received FDA 510(k) clearance on 2021-02-25. It is manufactured by Novoxel , Ltd.. The 510(k) number is K202988.

When was Tixel System approved by the FDA?

Tixel System received FDA 510(k) clearance on 2021-02-25, under approval number K202988.

What company makes Tixel System?

Tixel System is manufactured by Novoxel , Ltd..

What is the FDA product code for Tixel System?

The FDA product code for Tixel System is GEI.

Other Devices by Novoxel , Ltd.

K223033Tixel® 2 System K240512Tixel i (TXLI0001)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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