Cleared Traditional

K232930 - VERVE

K232930 is an FDA 510(k) clearance for VERVE, manufactured by Oculomotor Technologies. The device is a Class 1 Ophthalmic device with product code SBN cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K232930 · Oculomotor Technologies · Ophthalmic device
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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

FDA 510(k) Submission Details - K232930

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.

SBN Device Classification - Class 1, General Controls

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.