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FDA 510(k)

Tixel i (TXLI0001)

K-Number: K240512 · 2024-11-04

ApplicantNovoxel , Ltd.
Decision Date2024-11-04
Product CodeORZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Tixel i (TXLI0001) is a medical device manufactured by Novoxel , Ltd.. It received FDA 510(k) clearance on 2024-11-04 under approval number K240512. The device is classified under product code ORZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tixel i (TXLI0001)?

Tixel i (TXLI0001) is a medical device that received FDA 510(k) clearance on 2024-11-04. It is manufactured by Novoxel , Ltd.. The 510(k) number is K240512.

When was Tixel i (TXLI0001) approved by the FDA?

Tixel i (TXLI0001) received FDA 510(k) clearance on 2024-11-04, under approval number K240512.

What company makes Tixel i (TXLI0001)?

Tixel i (TXLI0001) is manufactured by Novoxel , Ltd..

What is the FDA product code for Tixel i (TXLI0001)?

The FDA product code for Tixel i (TXLI0001) is ORZ.

Other Devices by Novoxel , Ltd.

K202988Tixel System K223033Tixel® 2 System

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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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