Cleared Traditional

Tixel i (TXLI0001)

K240512 · Novoxel , Ltd. · Ophthalmic
Nov 2024
Decision
256d
Days
Class 2
Risk

About This 510(k) Submission

K240512 is an FDA 510(k) clearance for the Tixel i (TXLI0001), a Eyelid Thermal Pulsation System (Class II — Special Controls, product code ORZ), submitted by Novoxel , Ltd. (Netanya, IL). The FDA issued a Cleared decision on November 4, 2024, 256 days after receiving the submission on February 22, 2024. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5200.

Submission Details

510(k) Number K240512 FDA.gov
FDA Decision Cleared SESE
Date Received February 22, 2024
Decision Date November 04, 2024
Days to Decision 256 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code ORZ — Eyelid Thermal Pulsation System
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5200
Definition Therapeutic Application Of Heat And Massage To The Eyelids.