Cleared Traditional

K243819 - Luminopia (FDA 510(k) Clearance)

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

K243819 · Luminopia, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
118d
Days
Class 2
Risk

K243819 is an FDA 510(k) clearance for the Luminopia. Classified as Digital Therapy Device For Amblyopia (product code QQU), Class II - Special Controls.

Submitted by Luminopia, Inc. (Cambridge, US). The FDA issued a Cleared decision on April 9, 2025 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5500 - 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 Luminopia, Inc. devices

Submission Details

510(k) Number K243819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2024
Decision Date April 09, 2025
Days to Decision 118 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
8d slower than avg
Panel avg: 110d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QQU Digital Therapy Device For Amblyopia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5500
Definition A Digital Therapy Device For Amblyopia Is A Device That Incorporates Dichoptic Presentations On Visual Displays Through Therapeutic Algorithms To Treat Amblyopia Or To Improve Visual Acuity Of Patients With Amblyopia.
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
NCT06429280 Recruiting Observational Industry-sponsored

Clinical Data Registry of Amblyopia Patients on Luminopia Treatment

500
Patients (est.)
13
Sites
Condition studied Amblyopia
Eligibility All sexes
Sponsor Luminopia (industry)
Started 2023-09-01 → Primary completion 2026-12-31
Primary outcome
Change in Visual Acuity from baseline to consecutive visits
Secondary outcome
Visual Acuity analyses will also be conducted by Prior Treatment
View full study on ClinicalTrials.gov