Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart B — Diagnostic Devices](/submissions/OP/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 886.1120](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1120) → PJZ — Camera, Ophthalmic, General-Use

# PJZ · Camera, Ophthalmic, General-Use

_Ophthalmic · 21 CFR 886.1120 · Class 2_

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

## Overview

- **Product Code:** PJZ
- **Device Name:** Camera, Ophthalmic, General-Use
- **Regulation:** [21 CFR 886.1120](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/886.1120)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)

## Identification

An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

## Classification Rationale

Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, 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 (0 of 0)

_No cleared devices on record._

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

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