Tixel i (TXLI0001)— 510(k) K240512

Substantially Equivalent

Novoxel , Ltd.

FDA 510(k) clearance K240512 for Tixel i (TXLI0001), Substantially Equivalent on 2024-11-04. Applicant: Novoxel , Ltd..

Clearance details

Applicant: Novoxel , Ltd.
Product code: Code ORZ
Advisory panel: Ophthalmic
Date received: 2024-02-22
Decision date: 2024-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Netanya, IL

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