Camera, Ophthalmic, General-Use
The General-Use Ophthalmic Camera is a prescription imaging device indicated for the capture and storage of images of the eye and surrounding area in the general population, without specific diagnostic claims, disease references, or indications for particular patient subpopulations. It is an FDA Class 2 device regulated under 21 CFR 886.1120, within the Ophthalmic (OP) medical specialty. The product code is PJZ. The device must not exceed group 1 radiant exposure limits for UV, visible, and IR radiation as defined by the ANSI Z80.36-2016 standard.
Basic Information
- Product Code
- PJZ
- Device Class
- FDA class 2
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 52 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 52 registration numbers. Click on an entry to view related FDA registrations.