Cleared Traditional

K203594 - EyeCTester (FDA 510(k) Clearance)

Class I Ophthalmic device.

K203594 · Neuro-Eye Diagnostic Systems, LLC · Ophthalmic device
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Sep 2022
Decision
637d
Days
Class 1
Risk

K203594 is an FDA 510(k) clearance for the EyeCTester. Classified as Digital Amsler Grid (product code QTW), Class I - General Controls.

Submitted by Neuro-Eye Diagnostic Systems, LLC (Houston, US). The FDA issued a Cleared decision on September 7, 2022 after a review of 637 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1330 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Neuro-Eye Diagnostic Systems, LLC devices

Submission Details

510(k) Number K203594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2020
Decision Date September 07, 2022
Days to Decision 637 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
527d slower than avg
Panel avg: 110d · This submission: 637d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QTW Digital Amsler Grid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1330
Definition A Digital Amsler Grid Is Intended As An Aid In Detection Of Central Visual Irregularities Caused By Changes In The Visual Pathway In Patients.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Proxima Clinical Research, Inc.
Isabella Schmitt

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
NCT04607369 Enrolling by invitation Observational Industry-sponsored

Implementation of the NEDS EyeCTester App

Implementation of the NEDS EyeCTester App and NEDS Server Analysis Software Into the Homes of Patients With Neuro-ophthalmic, Retinal and Other Diseases to Enhance Early Detection of Active Eye Disease.

100
Patients (est.)
1
Site
Condition studied Optic Nerve Disease; Macular Disease; Visual Pathway Disorder
Eligibility All sexes · 18 Years+
Principal investigator Rosa A Tang, MD
Sponsor Neuro-Eye Diagnostic Systems, LLC (industry)
Started 2019-01-09 → Primary completion 2027-12-31 → Completed 2028-12-31
Primary outcome
Primary Outcome Measure for Groups 4a and 4b:
View full study on ClinicalTrials.gov