Cleared Traditional

K232930 - VERVE (FDA 510(k) Clearance)

Class I Ophthalmic device.

K232930 · Oculomotor Technologies · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jun 2024
Decision
267d
Days
Class 1
Risk

K232930 is an FDA 510(k) clearance for the VERVE. Classified as Digital Therapy Device For Convergence Insufficiency (product code SBN), Class I - General Controls.

Submitted by Oculomotor Technologies (Princeton, US). The FDA issued a Cleared decision on June 13, 2024 after a review of 267 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1290 - 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 Oculomotor Technologies devices

Submission Details

510(k) Number K232930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2023
Decision Date June 13, 2024
Days to Decision 267 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
157d slower than avg
Panel avg: 110d · This submission: 267d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SBN Digital Therapy Device For Convergence Insufficiency
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1290
Definition A Digital Therapy Device For Convergence Insufficiency Is An Electronic Device That Incorporates Binocular Presentations On Visual Displays To Treat Convergence Insufficiency
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

RQM+
Allison Komiyama, Ph.D., RAC

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.