Cleared Traditional

K223357 - EyeArt v2.2.0 (FDA 510(k) Clearance)

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

K223357 · Eyenuk, Inc. · Ophthalmic device
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Jun 2023
Decision
226d
Days
Class 2
Risk

K223357 is an FDA 510(k) clearance for the EyeArt v2.2.0. Classified as Diabetic Retinopathy Detection Device (product code PIB), Class II - Special Controls.

Submitted by Eyenuk, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 16, 2023 after a review of 226 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1100 - 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 Eyenuk, Inc. devices

Submission Details

510(k) Number K223357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2022
Decision Date June 16, 2023
Days to Decision 226 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
116d slower than avg
Panel avg: 110d · This submission: 226d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PIB Diabetic Retinopathy Detection Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1100
Definition A Retinal Diagnostic Software Device Is A Prescription Software Device That Incorporates An Adaptive Algorithm To Evaluate Ophthalmic Images For Diagnostic Screening To Identify Retinal Diseases Or Conditions.
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.

Clinical Evidence

ClinicalTrials.gov
NCT03112005 Completed Observational Industry-sponsored

Assessment of EyeArt as an Automated Diabetic Retinopathy Screening Tool

942
Patients (actual)
1
Site
Condition studied Diabetic Retinopathy; Diabetic Eye Problems; Diabetic Macular Edema
Eligibility All sexes · 18 Years+
Sponsor Eyenuk, Inc. (industry)
Started 2017-04-17 → Primary completion 2018-05-31
Primary outcome
Number of subject eyes whose EyeArt results match the reading center grading for identifying referable diabetic eye disease (moderate NPDR or higher on the ICDR scale or surrogate markers for CSME).
Study completed - no results published. This trial concluded in 2018 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov