Cleared Traditional

K220090 - Visibly Digital Acuity Product (FDA 510(k) Clearance)

Class I Ophthalmic device.

K220090 · Visibly, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2022
Decision
213d
Days
Class 1
Risk

K220090 is an FDA 510(k) clearance for the Visibly Digital Acuity Product. Classified as Digital Visual Acuity Test (product code QTO), Class I - General Controls.

Submitted by Visibly, Inc. (Chicago, US). The FDA issued a Cleared decision on August 12, 2022 after a review of 213 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1150 - 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 Visibly, Inc. devices

Submission Details

510(k) Number K220090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2022
Decision Date August 12, 2022
Days to Decision 213 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
103d slower than avg
Panel avg: 110d · This submission: 213d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QTO Digital Visual Acuity Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1150
Definition A Digital Visual Acuity Testing System Is Intended As An Aid In The Assessment Of Visual Acuity 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

Hogan Lovells US LLP
Janice M. Hogan

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
NCT05026658 Completed Interventional Industry-sponsored

Prospective, Randomized, Controlled Agreement and Reproducibility Clinical Study

A Prospective, Randomized, Controlled Clinical Study to Evaluate the Agreement and Reproducibility of Visibly Digital Acuity Product

358
Patients (actual)
3
Sites
Other
Purpose
Open label
Masking
Condition studied Digital Acuity Product
Study design Parallel
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Visibly (industry)
Started 2021-07-22 → Primary completion 2021-10-04
Primary outcome
Effectiveness
Secondary outcome
Effectiveness
Study completed - no results published. This trial concluded in 2021 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