# Camera, Ophthalmic, General-Use
> **Product code: PJZ** · Class II — Moderate Risk (510(k) clearance required) · Ophthalmic · 21 CFR 886.1120
## Classification
- **FDA Product Code:** PJZ
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 886.1120
- **Review panel:** OP
- **Medical specialty:** Ophthalmic
- **Submission type:** 4
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population.  PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 53
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PJZ)
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