Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1290](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1290) → SBN — Digital Therapy Device For Convergence Insufficiency

# SBN · Digital Therapy Device For Convergence Insufficiency

_Ophthalmic · 21 CFR 886.1290 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SBN

## Overview

- **Product Code:** SBN
- **Device Name:** Digital Therapy Device For Convergence Insufficiency
- **Regulation:** [21 CFR 886.1290](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1290)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A fixation device is an AC-powered device intended for use as a fixation target for the patient during ophthalmological examination. The patient directs his or her gaze so that the visual image of the object falls on the fovea centralis (the center of the macular retina of the eye.)

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K232930](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SBN/K232930.md) | VERVE | Oculomotor Technologies | Jun 13, 2024 | SESE |

## Top Applicants

- Oculomotor Technologies — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SBN](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/SBN)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com