QZP

Camera, Ophthalmic, Non-Prescription

Product code: QZP
Device name: Camera, Ophthalmic, Non-Prescription
Device class: Class 2
21 CFR: 21 CFR 886.1120
Medical specialty: Ophthalmic
Marketing pathway: 510(K)

FDA classification definition

Non-prescription ophthalmic camera is an AC or battery-powered device intended to take photographs of the eye and the surrounding area. The device is intended to be operated by a lay person and provide images available for evaluation by an eye care professional.

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

Official FDA classification page: QZP

Classification and pathway per current FDA publications. Data from openFDA (CC0).