Cleared Traditional

K240512 - Tixel i (TXLI0001) (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

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

K240512 is an FDA 510(k) clearance for the Tixel i (TXLI0001). Classified as Eyelid Thermal Pulsation System (product code ORZ), Class II - Special Controls.

Submitted by Novoxel , Ltd. (Netanya, IL). The FDA issued a Cleared decision on November 4, 2024 after a review of 256 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5200 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Novoxel , Ltd. devices

Submission Details

510(k) Number K240512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 110d · This submission: 256d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ORZ Eyelid Thermal Pulsation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5200
Definition Therapeutic Application Of Heat And Massage To The Eyelids.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Consultant

Regulatory Pathways Group, Inc.
Anne-Marie Ripley

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Clinical Evidence

ClinicalTrials.gov
NCT05162261 Completed Interventional Industry-sponsored

to Evaluate the Effectiveness and Safety of the Tixel® , VS LipiFlow® in the Treatment of Meibomian Gland Dysfunction

A Randomized, Masked (Evaluator), Controlled, Prospective Study Evaluating the Effectiveness and Safety of the Tixel® Medical Device, Versus LipiFlow® in the Treatment of Meibomian Gland Dysfunction

109
Patients (actual)
5
Sites
Treatment
Purpose
Single blind
Masking
Condition studied Meibomian Gland Dysfunction; Dry Eye Syndromes; Dry Eye
Study design Parallel
Eligibility All sexes · 22 Years+
Principal investigator Gregg Berdy, MD
Sponsor Novoxel Ltd. (industry)
Started 2022-09-19 → Primary completion 2023-04-26 → Completed 2023-09-28
Primary outcome
Changes in Tear Break Up Times (TBUT) to the 4-weeks Follow-up Exam
Secondary outcome
Changes in Patient OSDI
View full study on ClinicalTrials.gov