FDA 510(k)

Tixel i (TXLI0001)

K-Number: K240512 · 2024-11-04

Decision Date2024-11-04

Product CodeORZ

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Tixel i (TXLI0001) is the device name listed in this FDA 510(k) record. The listed applicant is Novoxel , Ltd.. It received FDA 510(k) clearance on 2024-11-04 under 510(k) 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. The listed applicant is Novoxel , Ltd.. The 510(k) number is K240512.

When did Tixel i (TXLI0001) receive FDA 510(k) clearance?

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

Who is the listed applicant for Tixel i (TXLI0001)?

The FDA 510(k) record lists Novoxel , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Novoxel , Ltd. as applicant

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.

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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.