PJZ

Camera, Ophthalmic, General-Use

Product code

PJZ

Device name

Camera, Ophthalmic, General-Use

Device class

Class 2

21 CFR

21 CFR 886.1120

Medical specialty

Ophthalmic

Marketing pathway

510(K) Exempt

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).