Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1435](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1435) → HIX — Maxwell Spot, Ac-Powered

# HIX · Maxwell Spot, Ac-Powered

_Ophthalmic · 21 CFR 886.1435 · Class 1_

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

## Overview

- **Product Code:** HIX
- **Device Name:** Maxwell Spot, Ac-Powered
- **Regulation:** [21 CFR 886.1435](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1435)
- **Device Class:** 1
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

A Maxwell spot is an AC-powered device that is a light source with a red and blue filter intended to test macular function.

## 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K831829](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIX/K831829.md) | KARICKHOFF FLYING CORPUSCLE VIEWER | Surgidev Corp. | Oct 19, 1983 | SESE |
| [K801554](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HIX/K801554.md) | STERILE CAST PADDING | Medi-Spec | Aug 4, 1980 | SESE |

## Top Applicants

- Medi-Spec — 1 clearance
- Surgidev Corp. — 1 clearance

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

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