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FDA 510(k)

Tixel® 2 System

K-Number: K223033 · 2023-06-21

ApplicantNovoxel , Ltd.
Decision Date2023-06-21
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tixel® 2 System is a medical device manufactured by Novoxel , Ltd.. It received FDA 510(k) clearance on 2023-06-21 under approval number K223033. 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® 2 System?

Tixel® 2 System is a medical device that received FDA 510(k) clearance on 2023-06-21. It is manufactured by Novoxel , Ltd.. The 510(k) number is K223033.

When was Tixel® 2 System approved by the FDA?

Tixel® 2 System received FDA 510(k) clearance on 2023-06-21, under approval number K223033.

What company makes Tixel® 2 System?

Tixel® 2 System is manufactured by Novoxel , Ltd..

What is the FDA product code for Tixel® 2 System?

The FDA product code for Tixel® 2 System is GEI.

Other Devices by Novoxel , Ltd.

K202988Tixel 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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